875 Pharmacovigilance Jobs - Page 3

Job Description Job Description Senior Specialist, Medical Affairs Our Medical Affairs team advances patient care by engaging in scientific exchange with external medical experts and industry leaders ensuring the scientific value of our products is understood. We connect, communicate and train internal employees to ensure a thorough understanding of the science behind the medicine and review further unmet medical needs to support collaboration to further differentiate our portfolio. THE OPPORTUNITY The Senior Medical Advisor (SMA) is primarily responsible for developing and implementing Medical Affairs Plans for their designated assets within the country. Their role involves facilitating the exchange of medical and scientific information between peers and key stakeholders, both internal and external. The SMA serves as an important collaborator on cross-functional teams that include Marketing, Training, Market Access, and Policy. They are tasked with proposing concepts for local data generation studies and, if these are prioritized and funded, securing approval from headquarters through the proper governance channels. The SMA is accountable for the timely execution, analysis, and publication of local studies. They foster trust with the external scientific community by engaging with scientific leaders and organizing country expert input forums to stay informed on advancements in therapy and patient care. Additionally, they effectively collaborate and lead efforts to address regulatory, reputational, ethical, and other asset management challenges within the country. WHAT YOU WILL DO Therapy Area to be handled will be Vaccines Primary Activities – Accountabilities, Supervision Asset Management & Business Leadership Gather actionable medical insights from the country that can inform the company’s strategic decisions. Convert the Global Medical Goals and Strategies into research initiatives, data analysis, scientific communication, educational efforts, and other tactics that aim to improve patient outcomes and enhance accessibility within the country. Follow up on investigator-initiated study proposals that align with the our company Investigator Study Program (MISP) areas of interest, adhering to the guidance outlined in the MISP Manual. Assist in executing the tactical plan and quickly adjust it to align with the business realities in the country. Operate with ethics and integrity by providing non-promotional, balanced, reliable, and scientifically sound information, while strictly adhering to company standards and local regulations. Scientific & Technical Leadership Integrate the insights of the country’s scientific and healthcare environment into the Regional Medical Affairs Team. Clearly and credibly communicate both scientific and business requirements to a wide variety of internal and external stakeholders at all levels. Build trust with the external scientific community through peer-to-peer exchanges, collaborative research, educational partnerships, interactions with scientific societies and health organizations, publications, and other related efforts. Deliver therapeutic and functional training to assigned teams and affiliate functions. Design and execute medical educational programs and symposia tailored to the country. Organize expert input forums within the country to inform and influence company strategy. Engage actively and contribute meaningfully to professional organizations, as well as academic and regulatory working groups. Regulatory Management Successfully collaborate and lead resolution of Regulatory, Reputational (i.e. Public Relations), Compliance and other Asset issues management Collaborate in the successful management of asset safety or quality issues, i.e. contribute content and strategy in regulatory responses and interactions, risk management planning and implementation Medical Information Provide prompt medical information support, such as research and answering of medical inquiries from external and internal customers, and review/approval of local response documents. About You Skills, Knowledge, Experience & Qualifications required MD, PhD, degree is required; recognized expertise through 5-10 years. Medical Affairs, Clinical and/or research experience, pharmacovigilance, governance and scientific leader management in the therapy area (Vaccines) is desired. Experience in launching innovative products, managing their life cycles, and understanding local pharmaceutical industry guidelines, as well as regulatory and reimbursement frameworks and clinical research guidelines. Strategic thinking skills, particularly concerning asset value proposition and evidence related to clinical and value-based outcomes. Ability to build a network of scientific leaders and successfully engage with other key stakeholders, including public groups, government officials, and medical professional organizations within various therapeutic areas. Desired experience in advocating for patient populations and improving healthcare access. Involvement in pursuing consensus recommendations and country-specific guidelines for various medical societies is preferred. Demonstrated capability to effectively communicate information at the country management level, with public groups, and to scientific leaders. Strong interpersonal, analytical, communication (both written and verbal), and project management skills that are results oriented. Excellent prioritization skills and an understanding of how decisions align with broader corporate strategies. Ability to collaborate effectively across functions in a matrix environment to achieve successful outcomes. Desired competency in budget management. Our Company Leadership Standards Applicable To The Role Include Make Rapid, Disciplined Decisions - Make timely decisions at the right level with the right data and support them once made. Act with Courage & Candor - Speak openly, honestly and with conviction have the courage to take appropriate risks and make difficult decisions. Demonstrate Ethics & Integrity - Adhere to the highest standards of trustworthy and ethical behavior in all interactions and hold others to the same standards; comply with all laws, policies and regulations; identify and address ethical issues without hesitation. Foster Collaboration - Actively listen and seek to understand differing perspectives; work together to achieve the common goals of the new to our company. Focus on Customers & Patients - Focus the entire organization on delivering value for customers, including patients, by understanding and meeting their needs. Drive Results - Set clear performance standards; overcome obstacles; hold our-selves and others accountable for achieving results. We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace. Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status Regular Relocation VISA Sponsorship Travel Requirements Flexible Work Arrangements Not Applicable Shift Valid Driving License Hazardous Material(s) Required Skills Preferred Skills Job Posting End Date 07/15/2025 A job posting is effective until 11 59 59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID R338824 Show more Show less

Company Description We are PrimeVigilance (part of Ergomed PLC), a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs and Quality Assurance. PrimeVigilance provides first class support to our small to large pharmaceutical and biotechnology partners maintaining long lasting relationships and has become one of the global leaders in its field. We cover all therapy areas including medical device. We love investing in our staff by providing an excellent training and development platform. We value employee experience, well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved. Come and join us in this exciting journey to make a positive impact in patient’s lives. Job Description Position Summary This role requires working as part of the Safety System Administrator Team performing database administration activities; supporting creation and upgrade of database instances; change control and data migration activities; first line user support and troubleshooting; and training users on databases. Principal Responsibilities The Safety System Administrator is primarily responsible for: Maintenance of database libraries Involvement in system validation activities Interrogating the database and generating outputs for internal and client use Training and providing database access to internal and client users Principle Functions For the Client (may include but is not limited to the following) Set up and maintenance of project specific database libraries including: Products Licenses Studies Reporting destinations Documenting and validating any change to the project specific database Support during legacy data transfer e.g., validation Supporting/providing guidance to the Project Manager / Client / Project Start Up Team during the development of project specific data handling guidelines (to ensure project specific guidelines are necessary and will not impact line listings and report generation) Prepare line listings and tabulations and other database outputs for use in aggregate reports, signal detection, reconciliation and other activities as required Provide case processing metrics required for invoicing (e.g., number of submissions, number of spontaneous vs initial cases processed) Provide database training to clients Providing and documenting client / internal team access upon receipt of an approved access request. For the Company (may include but is not limited to the following) Coordinate user access (including maintenance and revoking access) Maintain database procedures including core data handling conventions Provide database training and certification to PrimeVigilance users Provide user support Involvement in root cause investigation of database related deviations and ensure timely and complete documentation of resulting actions in line with Quality procedures Provide case processing quality and compliance metrics to the Quality Team Identify areas for improvement and address via training, clarifying changes to data handling guidelines, user guides etc. Execute business continuity periodic testing for database failure Ensure that existing software bugs, user requests, changes to regulatory requirements etc., are considered and appropriate changes are made and validated as required Support IT, database vendor and technical colleagues in troubleshooting and implementing software fixes and enhancements as required Other Supportive Responsibilities Assist PrimeVigilance senior management on an as needed basis. Potentially provide chargeable consulting / training activities to clients regarding Argus, and if required LSSMV. Qualifications Educated to degree standard Demonstrated work experience within Argus Safety Systems. Additional Information Why PrimeVigilance? We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow. To succeed we must work together with a human first approach. Why? because our people are our greatest strength leading to our continued success on improving the lives of those around us. We Offer Our core values are key to how we operate, and if you feel they resonate with you then PrimeVigilance could be a great company to join! We look forward to welcoming your application. Training and career development opportunities internally Strong emphasis on personal and professional growth Friendly, supportive working environment Opportunity to work with colleagues based all over the world, with English as the company language Quality Integrity & Trust Drive & Passion Agility & Responsiveness Belonging Collaborative Partnerships Show more Show less

Primary Responsibilities: Review and analyze patient medical records for accurate code assignment Ensure adherence to coding guidelines and regulatory requirements Learn to use medical coding software Apply understanding of anatomy and physiology to interpret clinical documentation and identify applicable medical codes Stay updated on industry changes and attend relevant training sessions Ensure confidentiality and security of all patient information Comply with the terms and conditions of the employment contract, company policies and procedures, and any and all directives (such as, but not limited to, transfer and/or re-assignment to different work locations, change in teams and/or work shifts, policies in regards to flexibility of work benefits and/or work environment, alternative work arrangements, and other decisions that may arise due to the changing business environment). The Company may adopt, vary or rescind these policies and directives in its absolute discretion and without any limitation (implied or otherwise) on its ability to do so #NTRQ Required Qualifications: Bachelors degree or masters degree, from a medical science backdrop or anything relevant Life Science or Bioscience, Pharmacy or Pharmaceutical Sciences, Nursing or Medicine Allied Health Good knowledge in medical terminology basics Good knowledge in Anatomy physiology basics Well-versed with ICD-10 guidelines and their implementation Proficient in reviewing medical records and determining the accuracy and completeness of the document Preferred Qualifications: AAPC/AHIMA Certification Risk Adjustment coding experience At UnitedHealth Group, our mission is to help people live healthier lives and make the health system work better for everyone. We believe everyone of every race, gender, sexuality, age, location and income deserves the opportunity to live their healthiest life. Today, however, there are still far too many barriers to good health which are disproportionately experienced by people of color, historically marginalized groups and those with lower incomes. We are committed to mitigating our impact on the environment and enabling and delivering equitable care that addresses health disparities and improves health outcomes an enterprise priority reflected in our mission.

Optum is a global organization that delivers care, aided by technology to help millions of people live healthier lives. The work you do with our team will directly improve health outcomes by connecting people with the care, pharmacy benefits, data and resources they need to feel their best. Here, you will find a culture guided by diversity and inclusion, talented peers, comprehensive benefits and career development opportunities. Come make an impact on the communities we serve as you help us advance health equity on a global scale. Join us to start Caring. Connecting. Growing together Primary Responsibilities: Review and analyze patient medical records for accurate code assignment Ensure adherence to coding guidelines and regulatory requirements Learn to use medical coding software Apply understanding of anatomy and physiology to interpret clinical documentation and identify applicable medical codes Stay updated on industry changes and attend relevant training sessions Ensure confidentiality and security of all patient information Comply with the terms and conditions of the employment contract, company policies and procedures, and any and all directives (such as, but not limited to, transfer and/or re-assignment to different work locations, change in teams and/or work shifts, policies in regards to flexibility of work benefits and/or work environment, alternative work arrangements, and other decisions that may arise due to the changing business environment). The Company may adopt, vary or rescind these policies and directives in its absolute discretion and without any limitation (implied or otherwise) on its ability to do #NTRQ Required Qualifications: Bachelors degree or masters degree, from a medical science backdrop or anything relevant Life Science or Bioscience, Pharmacy or Pharmaceutical Sciences, Nursing or Medicine Allied Health Good knowledge in medical terminology basics Good knowledge in Anatomy physiology basics Well-versed with ICD-10 guidelines and their implementation Proficient in reviewing medical records and determining the accuracy and completeness of the document Preferred Qualifications: AAPC/AHIMA Certification Risk Adjustment coding experience At UnitedHealth Group, our mission is to help people live healthier lives and make the health system work better for everyone. We believe everyone of every race, gender, sexuality, age, location and income deserves the opportunity to live their healthiest life. Today, however, there are still far too many barriers to good health which are disproportionately experienced by people of color, historically marginalized groups and those with lower incomes. We are committed to mitigating our impact on the environment and enabling and delivering equitable care that addresses health disparities and improves health outcomes an enterprise priority reflected in our mission.

Primary Responsibilities: To be an effective participant in Class room training and clear the training assessments with 85% quality Consistently meet the targets set for MOCK charts Eligible employee will get confirmed as Junior Coder within a max of 6 months from the Joining Punctuality, Attendance and General Adherence to company policies, procedures and practices Strives to provide ideas to constantly improve the process Ensure adherence to external and internal quality and security standards (HIPPA/ISO/ISMS) Be an effective team player Comply with the terms and conditions of the employment contract, company policies and procedures, and any and all directives (such as, but not limited to, transfer and/or re-assignment to different work locations, change in teams and/or work shifts, policies in regards to flexibility of work benefits and/or work environment, alternative work arrangements, and other decisions that may arise due to the changing business environment). The Company may adopt, vary or rescind these policies and directives in its absolute discretion and without any limitation (implied or otherwise) on its ability to do so #NTRQ Eligibility To apply to an internal job, employees must meet the following criteria: SG 22 can apply will move laterally Performance rating in the last common review cycle of Meets Expectations or higher Not be on any active CAP (Corrective Action Plan) or active disciplinary action Time in Role Guidelines Should have been in your current position for a minimum of 12 months, if you have not met the recommended minimum time in role, discuss your career interest with your manager and gain alignment prior to applying. And share the alignment email with respective recruiter while applying Required Qualifications: Any degree in Life Science or Bio-Science Any degree in Pharmacy or Pharmaceutical Sciences Any degree in Nursing or Allied Health Any degree in Medicine At UnitedHealth Group, our mission is to help people live healthier lives and make the health system work better for everyone. We believe everyone of every race, gender, sexuality, age, location and income deserves the opportunity to live their healthiest life. Today, however, there are still far too many barriers to good health which are disproportionately experienced by people of color, historically marginalized groups and those with lower incomes. We are committed to mitigating our impact on the environment and enabling and delivering equitable care that addresses health disparities and improves health outcomes an enterprise priority reflected in our mission.

Job DescriptionJob Description Responsible for assisting Project Management personnel with various tasks throughout the study lifecycle. ESSENTIAL DUTIES AND RESPONSIBILITIES: Assist with the Planning and Setup, Monitoring, and Closeout Phases of study management which may include: Database setup. Study documentation development. Equipment distribution/tracking. Report creation/distribution. Archival of study documentation. Coordinate Project Assurance meetings and assist with compiling meeting minutes and action items. Support financial components of study management including: Assistance with documentation/database updates due to scope changes. Follow-up related to invoice reconciliations. Preparation of reports in support of study forecasting activities. Facilitate issue management by documenting and tracking progress to ensure timely resolution to customer escalations. OTHER DUTIES AND RESPONSIBILITIES: Ensure compliance with timely training completion/documentation. Respond to customer inquiries and participate in customer calls/meeting upon Project Managers request. Take the lead in managing various aspects of a project as requested. Other related projects and tasks as assigned. QUALIFICATIONS AND SKILLS NEEDED: Education : Bachelor Degree preferred. Experience : At least 1-3+ years of experience in pharmaceutical field (or related industry experience). Knowledge of the drug development process. Good organizational, interpersonal, time management, and prioritization skills Excellent verbal and written communication skills, including ability to communicate effectively in English. Detail oriented and responsive to inquiries and requests. Working knowledge of Microsoft Office products.

General Summary: Provide financial analysis, modeling and research in support of potential real estate investment opportunities including acquisitions, dispositions and structured finance investments, as well as assist in the preparation of presentations to Investment Committee. Key Duties and Responsibilities: Create dynamic underwriting models in Excel with detailed property level cash flows in support of potential investment decisions; Prepare industry related research and analysis; Assist in preparation of memorandums and presentations to the Executive team; Work with various departments including legal, accounting, leasing, and property management to aggregate, interpret, and share information used to communicate both externally and internally for potential investments; Provide other support to the Investments team as needed. Job Specifications: BA/BS in finance, economics, accounting or related field, with up to six years of commercial real estate, corporate finance, or investment banking experience. Experience with Argus a must. Strong experience modeling real estate transactions with an in depth understanding of real estate fundamentals. Ability to understand and analyze financial statements (GAAP), leases, and related documents for purposes of forecasting, underwriting, and analyzing tenant credit quality. Organized and task oriented, able to work in a fast-paced, team-oriented environment with multiple deadlines, and adapt readily to changing priorities. Ability to convey technical information orally and in written correspondence, reports and presentations in a clear and concise manner. Highly skilled in Microsoft Excel and PowerPoint.

Medical Coding is the process of converting Verbal Descriptions into numeric or alpha numeric by using ICD 10-CM, CPT && HCPCS. As per HIPAA rules healthcare providers need efficient Medical Coders. Qualification & Specifications : MBBS,BDS,BHMS,BAMS,BSMS,PHARMACYB.Sc/M.Sc (Life Sciences / Biology / Bio Chemistry / Micro Biology / Nursing / Bio Technology), B.P.T, B.E BIOMEDIAL, B.Tech (Biotechnology/Bio Chemistry). 2020 -2024 passed out Skills Required: * Candidates should have Good Communication & Analytical Skills and should be Good at Medical Terminology (Physiology & Anatomy). Role: To review US medical records Initial file review for identifying merits Subjective review and analysis to identify instances of negligence, factors contributing to it To review surgical procedures, pre and post-surgical care, nursing home negligence To prepare medical submissions To prepare the medical malpractice case Regards Kowshika 7200652461

Urgent Walk in For M.Pharmacy fresher who are specialized in quality assurance only Eligible Developing and Implementing QA Systems and Procedures: Knowledge of quality assurance systems, and procedures creating SOPs (Standard Operating Procedures) Required Candidate profile Strong knowledge of cGMP and relevant regulatory requirements: This includes understanding manufacturing processes, quality control procedures, and validation requirements.

Company Description PrimeVigilance (part of Ergomed Group) is a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within Medical Information, Pharmacovigilance, Regulatory Affairs and Quality Assurance. PrimeVigilance provides first class support to our small to large pharmaceutical and biotechnology partners maintaining long lasting relationships and becoming one of the global leaders in its fields. We cover all therapy areas including medical device. We love investing in our staff by providing an excellent training and development platform. We value employee experience, well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved. Job Description The Financial Project Analyst has wide ranging responsibilities of PFA related duties. Work with Project Management Team to accurately forecast future units and revenue. Manage the financial health of our projects, working closely with the project to team to accurate record all financial data, report financial data clearly to the Project team. Monitor the total project cash positions. Responsible for all the financial aspects of assigned projects Ongoing maintenance of the financial and operational data within the companies’ management information structure Creation and distribution of scheduled reports Complete month end responsibilities including revenue recognition and forecasts, variance analysis, profitability analysis, and any other reporting needs as required Support Proposals & Contracts and Project Directors on the development of financial analysis for proposals Work closely with the Project Manager to provide on-going financial resource planning, management and analysis Supports the overall health of assigned projects Perform ad hoc financial analyses as requested by Project Managers and/or Department Heads Qualifications BA/BS degree in Business, Accounting, Finance, or equivalent education and experience. Demonstated relevant finance or accounting experience, project accounting/analysis a plus Pharmaceutical or CRO experience is preferable Strong proficiency in English Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) is essential Proficiency with accounting software packages Experience with Oracle Finance is preferred Knowledge in financial modelling techniques Excellent analytical skills Additional Information We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow. To succeed we must work together with a human first approach. Why? because our people are our greatest strength leading to our continued success on improving the lives of those around us. We offer: Training and career development opportunities internally Strong emphasis on personal and professional growth Friendly, supportive working environment Opportunity to work with colleagues based all over the world, with English as the company language Our core values are key to how we operate, and if you feel they resonate with you then PrimeVigilance could be a great company to join! Quality Integrity & Trust Drive & Passion Agility & Responsiveness Belonging Collaborative Partnerships Come and join us in this exciting journey to make a positive impact in patient’s lives. We look forward to welcoming your application. Show more Show less

Job Title - Life Sciences- Clinical Management Level : 9,11 Location: HYD, BLR, GGN, MUM; Must have skills: Working knowledge of clinical data management platforms such as Medidata/ RAVE, Veeva Clinical suite Good to have skills: Preferably worked with R&D functions such as Laboratory functions (R&D and Quality Check labs), clinical operations and development, decentralized clinical trials Job Summary: MBA from a Tier 1 institute or rich relevant industry experience 6+ years of progressive business and/or consulting experience; at least 1 year of experience in Life Sciences industry is mandatory Management consulting and general business consulting experience is a must Familiarity with assets OR tools in business consulting (R&D), such as issue trees, implementation frameworks, diagnosis tools like client questionnaire and analysis, operating model, business process mapping, and so on. Preferably worked with R&D functions such as Laboratory functions (R&D and Quality Check labs), clinical operations and development, decentralized clinical trials, pharmacovigilance, regulatory, quality management system, in capacity of a business analyst or management consultant. Working knowledge of clinical data management platforms such as Medidata/ RAVE, Veeva Clinical suite, pharmacovigilance databases ArisG & ARGUS databases, Regulatory Information Management Systems (Veeva RIM), lab informatics is desirable Roles & Responsibilities: Together, let’s deliver more effective, affordable, personalized patient outcomes. In this practice, you’ll help drive our Life Sciences clients’ strategy and business planning efforts, with the following initiatives: Support delivery of small to medium-size teams to deliver management consulting projects for global clients. Responsibilities may include strategy, implementation, process design and change management for specific modules Support efforts global sales team to identify and win potential opportunities within the practice. Provide industry expertise in various sub-segments of the LS industry Develop assets and methodologies, point-of-view, research or white papers for use by the team and larger community. Acquire skills that have utility across industry groups. Support on strategies and operating models focused on some business units and assess likely competitive responses. Also, assess implementation readiness and points of greatest impact. Co-lead proposals, business development efforts and coordinate with other colleagues to create consensus-driven deliverables. Execute a transformational change plan aligned with client’s business strategy and context for change. Engage stakeholders in the change journey and build commitment for change. Acquire skills that have utility across industry groups. Professional & Technical Skills: Bring your best skills forward to excel in the role: Industry expertise with a global top pharmaceutical, medical devices or biotechnology firm Familiarity or expertise with assets or tools in business consulting such as issue trees, implementation frameworks, diagnosis tools like client questionnaire and analysis, operating model, business process mapping, and so on Good functional and domain knowledge with relevant experience in the same area Make presentations wherever required to a known audience or client on functional aspects of his or her domain Should have worked with multi-functional teams and cross-functional stakeholders Ability to solve complex business problems and deliver client delight Strong writing skills to build point of views on current industry trends Strong program management skills Good analytical and problem-solving skills with an aptitude to learn quickly Good communication, interpersonal and presentation skills Additional Information: What’s in it for you? An opportunity to work on transformative projects with key G2000 clients Potential to co-create with leaders in strategy, industry experts, enterprise function practitioners and, business intelligence professionals to shape and recommend innovative solutions that leverage emerging technologies. Ability to embed responsible business into everything—from how you service your clients to how you operate as a responsible professional. Personalized training modules to develop your strategy & consulting acumen to grow your skills, industry knowledge and capabilities Opportunity to thrive in a culture that is committed to accelerate equality for all. Engage in boundaryless collaboration across the entire organization. About Accenture: Accenture is a leading global professional services company, providing a broad range of services and solutions in strategy, consulting, digital, technology and operations. Combining unmatched experience and specialized skills across more than 40 industries and all business functions — underpinned by the world’s largest delivery network — Accenture works at the intersection of business and technology to help clients improve their performance and create sustainable value for their stakeholders. With 569,000 people serving clients in more than 120 countries, Accenture drives innovation to improve the way the world works and lives. Visit us at www.accenture.com About Accenture Strategy & Consulting: Accenture Strategy shapes our clients’ future, combining deep business insight with the understanding of how technology will impact industry and business models. Our focus on issues such as digital disruption, redefining competitiveness, operating and business models as well as the workforce of the future helps our clients find future value and growth in a digital world. Today, digital is changing the way organizations engage with their employees, business partners, customers and communities. This is our unique differentiator. To bring this global perspective to our clients, Accenture Strategy's services include those provided by our Capability Network – a distributed management consulting organization that provides management consulting and strategy expertise across the client lifecycle. Our Capability Network teams complement our in-country teams to deliver cutting-edge expertise and measurable value to clients all around the world. For more information visit https://www.accenture.com/us-en/Careers/capability-network Accenture Capability Network | Accenture in One Word At the heart of every great change is a great human. If you have ideas, ingenuity and a passion for making a difference, come and be a part of our team. About Our Company | Accenture Experience: 3+ years of progressive business and/or consulting experience; at least 1 year of experience in Life Sciences industry is mandatory Educational Qualification: MBA from a Tier 1 institute or rich relevant industry experience Show more Show less

About the Company Qinecsa is a trusted, global partners bringing together best-in-class technology and scientific expertise to connect life science companies, public health, and regulatory sectors to the right safety solutions. we take pride in being the leading specialist pharmacovigilance provider, offering unparalleled expertise in PV services, technology, and consulting to cater to the unique needs of small, medium, and large pharmaceutical companies Location: India Job Type: Full-Time Job Description: We are seeking a Consulting Technology Project Manager to manage client implementation projects for our Pharmacovigilance SaaS solutions. The ideal candidate will be a dynamic client facing services professional with extensive project management experience in the life science technology domain. This is a strategic role requiring deep project management expertise, pharmaceutical domain knowledge, and excellent leadership skills. Key Responsibilities: Lead end-to-end project management of client software implementations, upgrades, and integrations. Develop and manage project plans, including timelines, budgets, and resource demand, and author project initiation documents. Coordinate cross-functional, global teams to ensure successful project delivery. Serve as the primary point of contact for senior client stakeholders, ensuring clear communication and strong relationship management. Ensure the accuracy, reliability, and performance of all project deliverables. Monitor project progress and performance, identifying and mitigating risks and issues as they arise. Facilitate regular project status meetings and provide updates to stakeholders. Actively manage project scope and costs, ensuring any changes are documented and approved through formal change control processes. Develop and maintain comprehensive project documentation, including project initiation documents, risk management plans, and post-project reviews. Ensure all projects comply with industry regulations, particularly those related to pharmacovigilance and data privacy (e.g. GxP, GDPR). Coordinate and manage interactions with third-party vendors, consultants, and partners to ensure successful delivery and integration of external components or services. Support continuous improvement of project management processes, tools, and best practices within the organization. Mentor and guide junior project managers and team members, fostering a collaborative and high-performance team environment. Characteristics: Well-organized self-starter with attention to detail. Excellent client facing communication and problem-solving skills. Strong written, communication, and interpersonal skills. A desire to learn about our proprietary products Essential Experience and Qualifications: Bachelor's or Master's degree in Computer Science, Information Technology, Project Management, or a related field. 8+ years of experience in project management, with at least 5 years in a senior or lead role delivering software solutions to pharmaceutical or life sciences clients. Proven experience managing pharmacovigilance, clinical, or regulatory technology projects. Knowledge of pharmacovigilance workflows and regulatory standards (e.g., ICH E2E, GVP Modules, FDA, EMA). Expertise in project management methodologies (e.g., Agile, Scrum, Waterfall). Proficiency in project management tools (e.g., Microsoft Project, Jira, SmartSheet). Preferred Experience and Qualifications: Familiarity with signal detection, case management, and safety databases (e.g., Argus, ARISg). Familiarity with cloud-based solutions and big data technologies. Technical background with experience in software development or IT infrastructure. Knowledge of regulatory requirements and industry standards for technology solutions. Certification in project management (e.g., PMP, PRINCE2). What We Offer: Competitive salary Opportunity to work with a dynamic and innovative team and world-class clients. Professional development and growth opportunities. A collaborative and inclusive work environment. Work from home with limited travel. How to Apply: Interested candidates are invited to submit their resume and cover letter to roopa.shree@qinecsa.com Show more Show less

Work Your Magic with us! Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That`s why we are always looking for curious minds that see themselves imagining the unimageable with us. Your Role Generate or convert doctors for our product portfolio. Secondary sales – Ensuring to achieve secondary sales targets through prescription generation by each of his BE. Good at relationship with KOLs (Top Physicians, Endocrinologists & Cardiologists) Day to day sales reporting Effective query handling and customer queries. Ensuring 100% Implementation of Company’s strategies Pharmacovigilance (Adverse Event Reporting) – To collect adverse drugs reaction (ADR) incidences including lack of efficacy related to medicinal products up to the maximum possible level of completeness and forward to local Patient Safety team immediately within 24 hours of ADR awareness. The additional information can be submitted as soon as possible Who You Are Any graduate Freshers or minimum of 1-2 years of experience in any pharma company Should have strong product knowledge & communication skills What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress! Apply now and become a part of our diverse team! Show more Show less

Description Safety Physician - ICSR Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong. Job Responsibilities Performs medical review of adverse events reported for investigational and marketed products Maintains familiarity with MedDRA, WHO-DRL, and safety databases such as ARGUS. Works closely with Safety and Pharmacovigilance (SPVG) colleagues to ensure appropriate medical interpretation and consistency are applied to adverse event case assessment Ensures regulatory and SOP compliance with respect to evaluation, reporting and surveillance of clinical and post-marketing safety information Identifies, communicates and effectively manages potential safety issues Interacts with client’s safety/medical personnel as appropriate Stays abreast of clinical and drug development information relevant to contracted programs Provides medical review and interpretation for aggregate safety reports (e.g. annual safety reports, PSURs, PADERs) Maintains medical and pharmacovigilance expertise through appropriate internal or external continued medical education Assists as a mentor and trainer for other internal safety staff including case processing staff Responsible for performing activities that are in compliance with applicable Corporate and D Departmental Policies, Standard Operating Procedures, Work Instructions and any project specific Operating Guidelines Performing other duties as assigned by management. Qualifications The incumbent should possess M.D., MBBS, D.O. Completed an accredited residency; Minimum of one to two (1 to 2) years of experience in clinical practice Minimum of one year of experience in the pharmaceutical, biotechnology, or device industry working in pharmacovigilance/epidemiology preferred Knowledge of global pharmacovigilance regulations and processes Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), Visio, email (Outlook), TeamShare (or other management/shared content/workspace), safety databases, and internet. Excellent verbal and written communication skills (proficient in English) as well as in the language required for case processing Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform and influence Ability to travel as necessary (up to 10%) Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Show more Show less

Roles and Responsibility Conduct thorough medical reviews of patient records, including diagnoses, treatments, and test results. Analyze medical information to identify trends, patterns, and areas for improvement. Collaborate with healthcare professionals to develop and implement effective treatment plans. Maintain accurate and up-to-date records of patient information and review findings. Participate in quality improvement initiatives to enhance the quality of medical care. Develop and maintain knowledge of medical terminology, regulations, and standards. Job Requirements Strong understanding of medical terminology, anatomy, and physiology. Excellent analytical, communication, and problem-solving skills. Ability to work effectively in a fast-paced environment with multiple priorities. Proficiency in using electronic health records systems and other healthcare software. Strong attention to detail and ability to maintain confidentiality. Ability to work collaboratively as part of a multidisciplinary team.

The key purpose of this role is to support Pharmacovigilance Operations PV Ops - ICSR Management in the following activities: ICSR Management Argus Configuration for new Programs/Studies ICSR processing Case Processing Coding Conventions Local Operating Companies (LOC) Interactions Functional Vendor Oversight: New Market Authorisation Withdrawal of Market Authorisation PAC awareness Clinical Trial/Program Interactions for: Study/Program Set up Study/ Program Maintenance Study/ Program Close out Argus Configuration for Submissions to destinations including Regulatory authorities Partners Clinical Research Organisations (CROs) LOCs Clinical Operations/CROs The position holder is responsible for the above elements in alignment with GSK standards and regulatory timelines whilst driving the implementation of robust processes for successful PV operations activities, including vendor oversight. Key Responsibilities Contribute to all aspects of case handling activities from case receipt to expedited reporting and collaborate with stakeholders (ie, the Safety Evaluation and Risk Management (SERM) group, local operating companies (LOCs) Application Development, Configuration and clinical operations/sciences) to ensure that documentation and processes are in place to achieve successful recording and reporting of safety data during the life cycle of a clinical trial and marketed product. Work across a complex matrix environment to drive high-quality delivery of case management activities that comply with internal standards and external regulatory requirements; where problems or issues are identified, facilitate investigation into root cause and create corrective/preventative actions (CAPAs) Escalate identified problems or issues to the appropriate Management Personnel with PV Operations Generate new ideas and proposals for global implementation; contribute to advancement of PV Operations methodology and processes. Ensures third parties/vendors develop and implement robust processes to support quality-driven organization. Demonstrate GSK values Supervise a team of up to 10 scientific staff (Global/ local) responsible for supporting ICSR Management activities. Manage team to ensure appropriate prioritisation and time management, in line with business needs Build external relationships with key stakeholders and senior leaders Provides project management and case processing oversight to ensures timely submission of expedite reports to Regulatory authorities, License Partners and CRO. Provides support and guidance to the ICSR Management Leads and team members to ensure compliance with global regulations and adherence to GSK SOPs Resolve issues and concerns within the ICSR Management team and escalate to ICSR Management Director, where resolution is not possible or there is impact across PV OPS Ensure that all ICSR Management activities are appropriately resourced and escalates any resourcing issues Provide workload forecasts and work with ICSR Management Director to strategically plan, in line with business goals Develop the team, identify training requirements and work with training team to establish required training plan for individuals as required Provide workload forecasts to PV Ops Directors and work with Director to strategically plan, in line with business goals Enhance matrix management across PV Ops, ensuring successful connections with PV Ops sub teams Education Requirements Degree in life sciences or medically related field or previous experience equating to educational requirements. Job Related Experience Knowledge of GSK products and business structure Project management experience Ability to map processes and author written standards Knowledge and experience with pharmacovigilance systems knowledge of GCP and GVP requirements and reporting of adverse events with a general understanding of world-wide requirements for PV Technical understanding of safety processes including regulatory interpretation, SOP/GUIs, Systems/data base conventions Direct experience working with outsourced providers

Job OverviewaApply knowledge and expertise for Safety Aggregate Report and Analytics (SARA) Center deliverables including safety aggregate reports, literature surveillance, signal management activities and benefit risk management documents. Essential Functions Serve as principal owner of the SARA deliverable and have responsibility for completion of the deliverable in compliance with all applicable service level agreements (SLA). Lead, author and finalize aggregate reports, including but not limited to PBRERs/PSUR, DSURs, PADERs, RMPs, ACOs, and line listings author responses to regulatory agency/ Pharmacovigilance Risk Assessment Committee (PRAC) inquiries, as required. Conduct/Lead ongoing literature safety surveillance for marketed and investigational products. Assist with the identification of ICSRs from literature, evaluation of events of special interests as well as aggregate data review. Act as Signal Management Lead on post-marketing and clinical trial projects. Set-up, implement, organize (including documentation) and lead safety management teams. Set-up and update products' signaling strategies. Author and/or QC review all types of signal management deliverables. Lead/ conduct ongoing signal detection activities as per agreed signaling strategies, perform signal validation and signal evaluation analyses for proactive and timely identification of signals and characterisation of risks . Responsible for full documentation and tracking of signals. In a PV support role, lead/author and/or QC review safety responses to regulatory agencies/PRAC and justification documents to support labelling documents. Interface with clients and other functional groups within Lifecycle Safety and other business units, such as Regulatory affairs Reporting (RR), Real World Late Phase (RWLP), Medical Writing, Clinical Research, Quality, Knowledge Quality Management (KQM), Pharmacovigilance Support (PVS), Project Leads (PL), Medical Safety Advisors (MSA), Qualified Persons for Pharmacovigilance (QPPV) / Pharmacovigilance Contact at National Level (PCNL), Library Information Services (LIS), Safety Operations (SO), and Information Technology (IT), as needed. Participate in internal and external audits and inspections, as required. Contribute to achievement of departmental goals e.g. utilization realization and productivity metrics. Read, acknowledge and adhere to all necessary IQVIA standard operating procedures (SOPs) and customer SOPs as required. Ensure all required training is executed in a timely fashion and documented. Serve as the interface between the global project lead and the working team conduct regular lessons learned with the working teams to ensure all information from the customer is cascaded to the relevant team members. Provide mentorship and training to less experienced resources. Provide regular reports to overall project manager and department management on project metrics, SOW changes, client requests or concerns participate in project review meetings with management communicate and document project issues to project team members and department management in a timely manner. Ensure Good Documentation Practices (GDP). Support and/or contribute to technology / innovation activities. Qualifications Bachelor's Degree In a Scientific or Healthcare discipline Req 2 - 3 years relevant work experience. Pref Equivalent combination of education, training and experience. Req Excellent knowledge of Lifecycle Safety services and processes. Intermediate willingness and aptitude to learn new skills across Lifecycle Safety service lines. Advanced In depth knowledge and understanding of applicable global, regional, local regulatory requirements. Intermediate i.e. Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP) and International Conference of Harmonization (ICH) guidelines, SOPs. Intermediate Proven ability to meet strict deadlines. Advanced manage competing priorities and ability to be flexible and receptive to changing demands. Intermediate Excellent organizational skills and time management skills. Intermediate Good working knowledge of Microsoft Office and web-based applications (e.g., Word, Excel, Powerpoint). Intermediate Good knowledge of medical terminology. Intermediate Proven ability to follow instructions/guidelines, work independently and on own initiative. Intermediate Excellent attention to detail and accuracy maintaining consistently high quality standards. Advanced Excellent written/verbal communication and report writing skills. Intermediate Sound judgment. Intermediate independent thinking and decision making skills. Intermediate Self-motivated and flexible. Advanced Ability to establish and maintain effective working relationships with coworkers, managers and clients. Intermediate Effective mentoring and coaching skills. Intermediate Good understanding of operational metrics, productivity and initiatives. Intermediate Demonstrate effective project management and leadership skills. Intermediate IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com Show more Show less

Clinical Operations Manager POSITION PURPOSE The COM 2 is a regional role that provides expertise across a ll aspects of clinical site management and/ or study management for assigned Phase I - IV studies. The COM 2 operates in line with Good Clinical Practices (ICH-GCP), applicable regulatory and legal requirements and Bayer s standard operating procedures. The COM 2 may be assigned work packages in areas of study start-up, site management and study management on a regional level. Either one or a combination of these work packages may be allocated to the position holder according to expertise, skill set and capacity requirements in a flexible way. The COM 2 must acquire knowledge and adequate training for work packages assigned and become proficient in independently executing assigned responsibilities. A work package is any combination of the individual responsibilities listed below. Work packages are not fixed, can be allocated per study, and distributed within the team. Allocation and distribution of responsibilities must adhere to Bayer s standard operating procedures, including any requirements for independent review and oversight. ROLE AND RESPONSIBILITIES STUDY MANAGEMENT Lead and oversee all operational aspects of site management on a regional or study level from protocol feasibility to study archive. Serve as the representative for site management on the core study team. Contribute to the development of the protocol, study overview, monitoring strategy and Risk Based Quality Management with regards to monitoring and operational aspects. Responsible and accountable for developing the monitoring plan and the study-specific training plan. Key contributor in the development of recruitment and retention strategies and tools. Act as key study contact for assigned countries. Responsible for overall deliverables regarding timelines, budget, and quality in assigned countries. Ensure participating country commitment aligns with study commitments. Provide the information required to effectively monitor and manage study activities, ensuring all relevant IT systems are updated with precise and current data. Oversee monitoring activities and ensure sponsor oversight through monitoring report review and co-monitoring visits. SITE MANAGEMENT Act as primary contact for investigational sites. Verify site qualification, ensure the Investigator, and site staff meet all aspects of study delivery and commitments from site selection through close out. Train the Investigator and site staff on study protocol, relevant systems and operational aspects of study conduct. Monitor trial conduct in compliance with the study protocol, ICH-GCP and applicable regulatory requirements on time and quality. Ensure completeness of the Investigator Site File. Prepare and conduct onsite and/or remote monitoring activities according to monitoring plan, including complete reporting and follow up. CLINICAL CUSTOMER ENGAGEMENT Cultivate and sustain customer relations with clinical trial sites, ensure effective communication, drive fit for purpose processes and work towards enhancing overall site satisfaction and engagement. Establish and develop strong professional relationships with clinical investigators to expand/ maintain clinical research partnership opportunities. Cross functional collaboration to ensure alignment of priorities and deliver the portfolio. Influence and challenge internal and external factors to improve clinical research delivery. STUDY START-UP Lead study start-up activities in collaboration with local team. Provide input on site activation strategy. Collect and perform quality review of essential documents on country level such as IRB/IEC approvals, financial disclosure, CVs/medical licenses, etc. Compile and submit submission dossier (country dependent). Obtain any required approvals for relevant site documents (e.g., informed consent, financial disclosures). Prepare and distribute site start up documentation including Investigator Site File. Ensure timely filing of study documents at country and site level in Trial Master File (TMF). Ensure awareness of related local regulations and support maintenance of country intelligence. Provide study status monitoring and systems support (e.g. act as technical expert) Coordinate site and vendor payments. QUALITY Proactively identify and communicate issues, taking appropriate action to prevent the recurrence of identified deviations. Ensure timely and comprehensive resolution of issues that may affectcompliance or the quality of study related activities or data. Maintain corrective action and preventative action plans (CAPAs) at country level. Contribute to the preparation, conduct, and follow-up of Site Audits and Regulatory Inspections to ensure a successful outcome. Oversee completeness of country/site level eTMF and conduct QC for accuracy, completeness, and adherence to ICH/GCP and Bayer QSDs. OTHER Participate in expert working groups, project standard teams, and similar initatives. Contribute to global process improvement efforts. Share knowledge and experience with a coaching mindset Maintain therapeutic and technical expertise to enable discussions with investigators and site personnel. KEY WORKING RELATIONS: Internal: Locally and regionally with other COM 2s, medical affairs, pharmacovigilance, regulatory affairs, legal and other functions. Globally with study team members, QA & Inspection management. External: With site personnel, third party vendors, health authorities, IRB/EC, and inspectors, thought leaders including steering committee members, national leaders and/or other committees. WHO YOU ARE: Healthcare related Bachelor s Degree or equivalent with minimum 4 years of monitoring and site management experience. Or have a combination of education and minimum 8 years of monitoring and site management experience. Other qualifications: Fundamental project management skills Awareness & understanding of cultural and regional differences Communication, oral presentation & interpersonal skills Decision making Issue resolution Planning and organization, time management, prioritization Thrives in ambiguous and collaborative environments and embraces change Effective written and verbal English communication skills Willingness to travel to sites, study meetings, local and international level Ever feel burnt out by bureaucracy? Us too. That s why we re changing the way we work for higher productivity, faster innovation, and better results. We call it Dynamic Shared Ownership (DSO). Learn more about what DSO will mean for you in your new role here Bayer does not charge any fees whatsoever for recruitment process. Please do not entertain such demand for payment by any individuals / entities in connection with recruitment with any Bayer Group entity(ies) worldwide under any pretext. Please don t rely upon any unsolicited email from email addresses not ending with domain name bayer.com or job advertisements referring you to an email address that does not end with bayer.com . Location: India : Karnataka : Bangalore || India : Maharashtra : Thane Division: Pharmaceuticals Reference Code: 848115 Contact Us + 022-25311234

This job is with Parexel, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly. Job Purpose Provide medical review, analysis and guidance during the case handling and reporting cycle of Adverse Event and Adverse Reaction reports received for investigational and marketed products Provide medical guidance and input to Drug Safety Associates (DSAs) and specialists in medical aspects of drug safety Function as pharmacovigilance representative/safety scientist General Maintaining a good working knowledge of the Adverse event profile of assigned products, labeling documents, data handling conventions, client's guidelines and procedures, and international drug safety regulations Maintaining an awareness of global regulatory requirements and reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting Maintaining excellent knowledge of the safety profile of assigned products Communicating and discussing issues related to review process with Project Manager Interacting with internal and external contacts for resolving issues Maintaining a good working knowledge of relevant regulatory guidelines Attend and present client/cross functional meetings along with other stakeholders Training and mentoring new team member, as required Working as Subject Matter Experts (SMEs) Assisting the Manager for inspection readiness activities and audits Provides inputs for process improvisations Works closely with Manger for process co-ordination and to ensure meeting all KPIs for the process. Case report Medical review (as applicable) Performing medical review of cases according to client Standard Operating Procedures (SOPs) and liaising with the client, as required Writing Pharmacovigilance/Marketing Authorization Holder (MAH) comment and assessing company causality Assessing seriousness and expectedness of reported events Providing medical advice to DSPs and case processing team Skills Excellent interpersonal, verbal and written communication skills Computer proficiency, an ability to work with web-based applications and familiarity with the Windows operating system Client focused approach to work A flexible attitude with respect to work assignments and new learnings Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail Ability to assess the clinical relevance of medical data and to interpret its clinical meaning is essential Willingness to work in a matrix environment and to value the importance of teamwork Strong knowledge of international drug regulation including GCP, GVP Knowledge And Experience Relevant experience of minimum 2 Years in Pharmacovigilance/ drug safety is desirable. Education MBBS/Post Graduation in Medicine. Show more Show less

This job is with Parexel, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly. Job Title: Safety Data Exchange Agreement (SDEA) Drug Safety Specialist Job Summary: The SDEA Pharmacovigilance (PV) Specialist is responsible for managing Safety Data Exchange Agreements between the company and its partners in the contract management database, ensuring compliance with global pharmacovigilance regulations and facilitating efficient exchange of safety information, coordinating with various stakeholders, manage the lifecycle of SDEAs/PVAs for business relationships ensuring to meet the standard process and applicable regulatory requirements. Responsible to assess contractual information related to PV obligations on different type of reports like individual case safety reports, aggregate reports, signal reports, literature screening and other PV related aspects. Key Responsibilities Management of Global and Local SDEAs (SDEA / PV clause / Pharmacovigilance Agreement / Vigilance Agreement, PV Agreement for Clinical Supply, Divestments) for investigational, post marketing, marketed products, vaccines and medical devices. Review and assessment of PV obligations from contracts on different type of reports ICSR processing and timelines, PSURs/PBRERs, RMPs, Signal detection, Clinical study reports, periodic line listings, literature screening, labeling etc. to ensure accurate information is entered in the database. Management of Safety database related configuration requests and updates. Build and manage reports (Business Partner lists) periodically from the Contract management database to provide the operational functions with the latest contacts list for implementation in their processes or systems Maintain a database of all agreements and track their status, expiration dates, and amendments. Provide guidance on SDEA-related issues to stakeholders and non-stakeholders. Ensure timely execution of SDEAs in the database to support project timelines. Strict adherence to the standard operating procedures (SOPs) and guidelines. Ensure all executed PVAs and its Main agreements are tracked within Global Comprehensive tracker and filed within dedicated share folder. Provide support in ad-hoc activities to support the periodic aggregate teams for preparation of PSURs/DSURs Efficient in mailbox management and reconciliations. Conduct training sessions on SDEA processes and requirements for relevant staff. Perform Quality check on the processed data entries. Monitoring of Key performance indicators (KPIs) and metrics. Stay current with global pharmacovigilance regulations and industry best practices. Participate in audits and inspections related to safety data exchange processes. Qualifications Bachelor's degree in Life Sciences, Pharmacy, or a related field. Advanced degree preferred. 2-3 years of experience in pharmacovigilance, clinical research, or a related field. Knowledge And Experience Related experience in drug safety/ pharmacovigilance and contract (SDEA/PVA) management is desirable Strong knowledge of global pharmacovigilance regulations and guidelines (e.g., ICH, EMA, FDA). Strong knowledge of pharmacovigilance terminologies on Individual case safety reports, Aggregate safety reports, Signal and risk management, and related regulations and guidelines (e.g., ICH, EMA, FDA). Strong knowledge about the master service agreements and terminologies. Experience in management of the ICSRs in safety database. Understanding of medical terminology and adverse event coding. Experience in automation / artificial intelligence would be an asset. Desired Skills Sound knowledge of drug safety, data analysis and evaluation of safety data Ability to work collaboratively and effectively in a team environment Client focused approach to work Ability to evaluate data and draw conclusions independently Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail Computer proficiency, IT skills, the expertise and ability to work with web-based applications, and familiarity with the Windows Operating system and the MS Office suite (Word/Excel/Power Point) Show more Show less

Pharmacovigilance/ Sr Pharmacovigilance Associate ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. Roles & Responsibilities Review and process safety events (pre-marketing, post-marketing, medical device and drug) and/or other medically related information per assigned tasks and project specific procedures Perform review of abstracts and full articles to identify safety information from literature source for both pre and post marketed products. Generates data listings from the safety database and assumes responsibility for accuracy of the data. Complete adverse event follow-up in writing and/or by phone based on requirements for each Client. Provide input and review relevant safety tracking systems for accuracy and quality and assist with maintaining project files* Perform safety review of clinical and diagnostic data as part of case processing. Responsible for effective and efficient development of the Safety Management Plan, including development of specific processes to assure consistency within the project. Support creation of post-marketing safety activities, such as PSMF, RMP and PBRER Support Qualified Person for Pharmacovigilance as required. Liaise with investigational site, reporter, and/or Sponsor as necessary regarding safety issues. Liaise with ICON Medical Monitor, project manager, and other departments, as appropriate. Assist with identifying out of scope activities in conjunction with the Pharmacovigilance Project lead (as applicable) Attend project team and Sponsor meetings and teleconferences as required including presentation of the safety process at kick-off and investigator meetings. Supports the generation of Aggregated Safety Reports (e.g. Development Safety Update Report, IND Annual Report, Periodic Safety Update Reports, and other cumulative safety reports) through data retrieval and other assigned tasks. Supports interim data analysis for DMC reviews. Effectively maintains the safety database and corresponding entry guidelines, including assurance of quality of data following established quality control process. Supports creation of the SAE/AE reconciliation plan and supports SAE reconciliation in accordance with this plan and other project specific guidelines. Supports Safety Scientist in signal detection and risk management activities. Assures consistency of plans with client contract and identifies out of scope activities promptly and accurately. Proposes solutions for procedural and technical issues. Supports audits and inspections as required for the assigned projects. Perform other activities as identified and requested by management including but not limited to: Respond and process medical information inquiries including inquiries related to adverse events and product complaints for Clients’ product(s), as per their agreement with ICON. What You Will Be Doing Collecting and reviewing adverse event reports to ensure accurate and timely reporting in accordance with regulatory guidelines. Conducting signal detection and risk assessment activities to identify potential safety issues. Collaborating with cross-functional teams to support safety-related inquiries and investigations. Maintaining up-to-date knowledge of pharmacovigilance regulations and industry best practices. Assisting in the preparation of safety reports and regulatory submissions. Your Profile Bachelor's degree in life sciences, pharmacy, or a related field; advanced degree preferred. Experience in pharmacovigilance, drug safety, or a related area, preferably within a clinical or pharmaceutical environment. Strong analytical skills with attention to detail in data collection and reporting. Excellent communication and interpersonal skills, enabling effective collaboration with team members and stakeholders. A commitment to maintaining high standards of quality and compliance in all pharmacovigilance activities. What ICON Can Offer You Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our Benefits Examples Include Various annual leave entitlements A range of health insurance offerings to suit you and your family’s needs. Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being. Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply Show more Show less

Role & responsibilities Lead, mentor, and manage the Pharmacovigilance QA team to ensure effective execution of QA activities. Develop, implement, and maintain QA processes, procedures, and tools aligned with regulatory guidelines (e.g., ICH, FDA, EMA). Monitor and ensure compliance of pharmacovigilance activities with applicable regulations and internal SOPs. Conduct risk assessments and develop mitigation plans to ensure PV compliance . Oversee the management and closure of CAPAs (Corrective and Preventive Actions) following audits or inspections. Plan, coordinate, and conduct internal and external audits of PV processes, systems, and vendors audits ( Risk Based Audit approach ). Lead audit preparedness activities and ensure timely resolution of audit findings. Collaborate with cross-functional teams to implement audit recommendations and continuous improvements. Maintain audit documentation and track audit metrics for management review. Ensure all QA activities support compliance with global pharmacovigilance regulations, including GVP (Good Pharmacovigilance Practices). Participate in regulatory inspections and provide QA support as needed. Review and approve quality documentation related to PV activities such as SOPs, training materials, and audit reports. Identify QA training needs for the PV team and develop training programs accordingly. Conduct and coordinate training sessions on quality standards, SOPs, and compliance requirements. Promote a quality culture and awareness within the PV department. Identify gaps and areas for improvement within PV and QA processes and implement best practices. Collaborate with PV operations and other departments to optimize workflows and enhance quality outcomes. Utilize metrics and KPIs to monitor quality performance and drive continuous improvement. Act as the key liaison between PV, QA, regulatory affairs, and other stakeholders. Provide guidance and support on quality-related matters to internal teams and external vendors. Facilitate effective communication to ensure alignment on quality expectations and deliverables. Plan, assign, and review work for QA team members and provide ongoing feedback and development opportunities. Facilitate team meetings and promote continuous communication and knowledge sharing within the team. Support recruitment, onboarding, and performance management of QA staff. Preferred candidate profile Bachelors degree in Pharmacy, Life Sciences, or related field (Master’s preferred). Extensive experience (typically 7+ years) in Pharmacovigilance with significant exposure to QA activities. Strong knowledge of global pharmacovigilance regulations, GVP, and quality management systems. Proven leadership and team management skills. Experience in conducting audits and managing CAPAs . Excellent communication, organizational, and problem-solving skills. Ability to work collaboratively with cross-functional teams and external vendors.

Paytm is India's leading mobile payments and financial services distribution company. Pioneer of the mobile QR payments revolution in India, Paytm builds technologies that help small businesses with payments and commerce. Paytm’s mission is to serve half a billion Indians and bring them to the mainstream economy with the help of technology. About the team Oil & Gas This team is directly responsible for growth of Oil and Gas offline transactions & users at Paytm. About the role Team Leader To work with the business to understand and manage Programs being run for the Clients/Brands. And for accelerating the core growth metrics focusing on sales & distribution. Provides guidance and instruction to a working group about a project or portfolio of projects. These leaders are responsible for monitoring the efforts of the team members and getting the work done effectively and efficiently with the proper utilization of resources. Skills that will help you succeed in this role: 2+ yrs. of experience in Distribution sales in fintech, Banking/ Sales, EDC Sales. Develop plans and strategies for developing business and achieving the company's sales goals. Create a culture of success and ongoing business and goal achievement. Manage the sales teams and resources to deliver growth. Hire and build a new team to support our growing needs and future projects. Define optimal sales force structure. Define and coordinate sales training programs that enable staff to achieve their potential and support company sales objectives. Manage customer expectations and contribute to a high level of customer satisfaction. Define sales processes that drive desired sales outcomes and identify improvements. Going to the Merchant and educating him/her about the benefits of the Swipe machine (EDC) converting them and managing their accounts. Exceptional communication, presentation skills and relationship building skills. Ability to aggressively manage the successful execution of a sales strategy. Ability to work independently and collaboratively in a team environment. Qualifications: Bachelor's degree in business, marketing, or a related field (MBA preferred). Should have a strong understanding of the local language. Self-motivated and goal-oriented, with a demonstrated ability to work independently and as part of a team. Willingness to travel as needed to meet with clients and attend industry events.

TCS is Hiring - Pharmacovigilance Location - Mumbai, Pune Responsibilities: Ability to understand and analyses the complex data and performs the activities including accessing the case in Argus, code and enter data. Be fully competent to perform all steps within the case-handling process. Ensure compliance with global and local procedural documents and local implementation of Patient Safety objectives, policies, processes and procedures. Responsible for follow up procedures. Contribute to the development and implementation of new safety-related systems, processes and procedures within the process. Support a performance-driven culture. Excellent communication skills (verbal and written) Ability to work in team and meet the strict timelines of delivery. Show more Show less

Skill required: Clinical Data Services - Clinical Database Programming Designation: Clinical Data Svs Analyst Qualifications: BSc/Master of Pharmacy Years of Experience: 3 to 5 years Language - Ability: English(International) - Expert About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song— all powered by the world’s largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world’s leading biopharma companies bring their vision to life – enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience. The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. They help identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The team also managing clinical data management projects. You will be expected to develop and review complex edit checks, patient profile listings, reports, preprocessing checks & map datasets for validation based on study requirements using different tools/techs such as Cognos / SAS, J-Review, or any other applicable systems. What are we looking for? Adaptable and flexible Ability to perform under pressure Problem-solving skills Detail orientation Ability to establish strong client relationship Roles and Responsibilities: Data Review Report Programmers: Overall experience of 4+ years in Clinical review and reporting programming, business analytics and/or clinical trial setup, gained in the pharmaceutical industry, CRO or Life Science related industry preferred. Participate in the lifecycle of producing key data and/or reports in support of data review reporting development including evaluation of requirements, design specifications, interface to programmers, report programming, coordinate validation and rollout activities along with providing quantitative analytical support. Provide understandable and actionable reports on clinical data and monitoring of clinical data for key stakeholders. Facilitate interaction with end user on creating specifications and working with programmers or performing the programming activities for successful delivery. Program reports of various complexity from documented requirements, within the clinical reporting systems using SQL, PL/SQL, SAS, and JReview etc. preferred. BSc,Master of Pharmacy Show more Show less