874 Pharmacovigilance Jobs

Note: This role would involve Rotational Shifts (Morning and Nights) Basic roles: Patient care Maintain compliance Clinically sound Assist the surgeon/Consultant Roles and Responsibilities Basic roles: Patient care Maintain compliance Clinically sound Assist the surgeons

PMS College of Dental Sciences & Research is looking for Asst Proffesor - Pharmacology to join our dynamic team and embark on a rewarding career journey Develop and deliver high-quality lectures and instructional materials. Conduct research and publish findings in academic journals. Advise and mentor students on academic and career matters. Participate in academic committees and contribute to curriculum development. Stay current with developments in the field and incorporate them into teaching.

Lilavati Medical Center is looking for Clinical Associate - Radiology to join our dynamic team and embark on a rewarding career journey Perform and interpret diagnostic imaging procedures, including X-rays, MRI, CT scans, and ultrasounds. Provide expert consultation to other physicians regarding radiologic findings. Ensure high-quality imaging and patient safety. Stay updated with advancements in radiology technology and techniques. Participate in multidisciplinary team meetings to discuss patient care plans. Conduct research and contribute to radiology publications. MD/DNB (Radiology) with post graduate experience from a reputed Hospital.

Job Title: Director – Clinical Research Location: Greater Noida Experience Required: 5–10 Years in Clinical Research Educational Qualification: Ph.D., MD, or MPH (or equivalent) in a relevant scientific discipline (e.g., Biology, Medicine, Pharmacy) Budgeted CTC: Upto ₹36 LPA Employment Type: Full-Time | Onsite About the University: Our Client is a NAAC A+ accredited, multidisciplinary university in Greater Noida that fosters global learning, cutting-edge research, and innovation. With over 20,000 students from 85+ countries, the university is one of India’s leading education providers with a focus on holistic and interdisciplinary education. Position Overview: We are seeking a highly qualified and experienced Director – Clinical Research to lead and oversee clinical trials and research initiatives within our organization. The ideal candidate will have strong expertise in clinical research, particularly in oncology , and possess a deep understanding of global clinical trial regulations, study design, and execution. This role requires strategic thinking, team leadership, and the ability to manage multiple concurrent research projects in a fast-paced environment. Key Responsibilities: Leadership & Strategy: Lead and oversee all clinical research activities, ensuring alignment with organizational goals and regulatory requirements. Develop and implement clinical trial strategies, including protocol design, study planning, and risk mitigation. Provide mentorship and guidance to clinical research teams and collaborators. Clinical Trial Management: Oversee the planning, initiation, execution, and close-out of clinical trials. Ensure compliance with FDA regulations, ICH GCP guidelines, and applicable local regulations. Coordinate with CROs, investigators, and site staff for study implementation and monitoring. Regulatory & Compliance: Prepare and review clinical protocols, Investigator Brochures (IBs), informed consent forms, and regulatory submissions. Ensure ethical and regulatory compliance throughout all research activities. Data Analysis & Reporting: Collaborate with biostatisticians and data managers to analyze clinical data. Interpret study results and oversee preparation of study reports, publications, and regulatory documentation. Stakeholder Engagement: Liaise with cross-functional departments including medical affairs, pharmacovigilance, and R&D. Represent the organization in scientific meetings, regulatory discussions, and industry forums. Desired Candidate Profile: Educational Background: Ph.D., MD, or MPH in a relevant scientific field such as biology, medicine, pharmacology, pharmacy, or public health. Experience: Minimum 5–10 years of progressive experience in clinical research, with a strong track record in managing trials from concept to completion. Prior experience in oncology research is highly preferred. Experience working with global clinical trial regulations, particularly FDA and ICH GCP. Skills & Knowledge: Excellent knowledge of clinical trial design, regulatory pathways, and protocol development. Proficiency in statistical software (e.g., SAS, SPSS, R), data management tools (e.g., Medidata, Oracle Clinical), and relevant e-clinical systems. Strong communication, leadership, and problem-solving skills. Ability to work collaboratively in a cross-functional environment. Key Competencies: Strategic thinking and project leadership Clinical compliance and operational excellence Scientific acumen and data interpretation Team mentoring and stakeholder management Attention to ethical and quality standards Application Process: Interested candidates may send their updated CV and a brief statement of clinical leadership experience to: [connect@coral-ridge.com] | Subject Line: Application for Director – Clinical Research Shortlisted candidates will be contacted for an in-depth discussion and final round of interaction. Job Types: Full-time, Permanent Pay: ₹3,000,000.00 - ₹4,000,000.00 per year

Company Description Clinformatiq is a leading Clinical Research and Healthcare IT training institute dedicated to bridging the gap between academics and industry. We provide comprehensive training in Clinical Research, Pharmacovigilance, CDM, Regulatory Affairs, Medical Coding, and Clinical SAS. Our programs are designed to prepare graduates for real-world roles through hands-on learning and industry tie-ups. Our mission is to empower students with the right skills and connect them to top career opportunities in the life sciences sector. Role Description This is a full-time, on-site role located in Guntur for a Business Development Associate. The Business Development Associate will be responsible for generating leads, conducting market research, and preparing and delivering presentations. In addition, the role will involve maintaining effective communication with potential clients and stakeholders to drive business growth. Qualifications Lead Generation and Market Research skills Presentation Skills and ability to create and deliver Presentations Strong Communication skills Excellent interpersonal and organizational skills Ability to work independently and as part of a team Experience in the healthcare or education sector is a plus Bachelor's degree in Business, Marketing, or related field Requirements: Male Candidates Only

Role- Medical Reviewer(MCI Cert.) MBBS/MD Graduates with 1 yr to 8 yrs of Clinical/Non Clinical Exp in Clinical Trials, PV, ICSR, SUSAR 5 Days WFO| 2 RWO| General Shift SALARY UP-TO 18LPA CALL- RUKHSAR- 9899875055 SUHANI- 9911988552 Divya- 9911988842

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.

Manager, Safety & PV (Japanese Language Professional) 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 Line management responsibilities including transfers, hiring, utilization, terminations, training, professional development, performance appraisals, time sheet approval, and employee counseling. Advises staff on administrative policies and procedures, technical problems, and prioritization. Assigns project work and reviews workload for all direct reports. Provides oversight and guidance on organizational goals and company objectives. Monitors quality of work and efficiency of team members with contracted scope of work and Safety Management Plan. Discusses below-target project goals with senior safety management. Manages projects where Safety and Pharmacovigilance are the primary services. o Reviews study budgets and expenses; ensures all study related contractual and budgeting issues are upheld and performed. o Works with Finance to ensure appropriate customer invoicing, where required. o Approves project time cards and invoicing. o Provides sponsors with scheduled project updates and reports. o Coordinate with other internal departments and Safety functional areas to ensure timely review and submission of reports and documents relating to safety reporting as well as resolution of issues. Participates in the management of the Safetyand Pharmacovigilance department with the following actions: o Assists in the development, review, and approval of departmental Standard Operating Procedures (SOPs) o Reviews, provides input, and ensures the execution of the Safety Management Plan/Safety Reporting Plan. o Evaluates processes for potential improvement in efficiency and effectiveness and recommends changes. Participates in process development and improvement of departmental functions. o Works with Business Development to actively solicit new business, as needed. o Represents Safety and Pharmacovigilance or ensure Safety representation at project team meetings and client meetings. Reviews, advises, and approves Safety portions of project proposals to ensure wording adequately reflects the scope of work for Safety and Pharmacovigilance. Participates in bid defense meetings. Reviews clinical safety sections of study protocols and Case Report Forms (CRFs) to make sure information is consistent with the Serious Adverse Event form. Approves budget projections for the project. Maintains understanding and ensures compliance of SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCPs, ICH guidelines, GVP modules, study plans and the drug development process. Responsible for the identification, preparation, and delivery of any necessary training to Safety team members and other Syneos Health departments or groups. Mentor Safety team members Managing resourcings needs/issues and escalating to senior management as necessary. Participates in audits/inspections and ensures inspection readiness. Participates in quality investigations and implementation of corrective and preventive actions. Performs other work related duties as assigned. Minimal travel may be required. Qualifications - Must be a N3 or above certified (JLPT) Japanese Language professional - BA/BS in the biological sciences or related disciplines in the natural science/health care field or nursing degree or equivalent combination of education and experience Progressive responsibility with demonstrated leadership skills and project management Clinical Research Organization (CRO) experience with therapeutic specialties preferred Working knowledge of financial budgets and various financial analysis tools preferred Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), Visio, email (Outlook), TeamShare (or other management/shared content/workspace), and internet Excellent oral, written, and interpersonal communication skills with strong graphic presentation skills Ability to establish effective relationships with clients as well as team members Ability to be flexible, adapt to change, work independently, as well as part of a teamin a matrix environment Ability to make effective decisions and manage multiple priorities while delivering high quality work in a dynamic environment 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.

We are seeking life science graduates interested in building a long-term career in the Clinical Research domain. This opportunity is part of our industry-integrated Clinical Research Training Program designed to prepare candidates for roles such as CRA, CRC, and Drug Safety Associate . Role Responsibilities (Post-Training Readiness) Understand and support clinical trial processes, site coordination, and documentation Learn Good Clinical Practices (GCP), ICH guidelines, and regulatory frameworks Monitor data collection and compliance Collaborate with CROs, hospitals, and research organizations (Post-placement) Eligibility Criteria Education: B.Sc, B.Pharm, M.Sc, BDS, BPT, BHMS, BAMS, Nursing, MBBS Background: Life Sciences or Healthcare domain Experience: 02 years Location: Open to all Indian cities (program delivered online & offline) Must have interest in Clinical Trials, Research, Pharmacovigilance, or Regulatory Affairs

Skill required: Clinical Data Services - Clinical Reports Management Designation: Clinical Data Svs Sr Analyst Qualifications: BE/BTech/MCA Years of Experience: 5 to 8 years 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. In this role, you will be expected to develop clinical trial reports using SAS/ J-review / Congnos / SQL / PLSQL as per the study requirement. What are we looking for? Clinical Database Programming Clinical Data Management Oracle Procedural Language Extensions to SQL (PLSQL) Adaptable and flexible Ability to perform under pressure Problem-solving skills Agility for quick learning Ability to work well in a team SAS Clinical Structured Query Language (SQL) Roles and Responsibilities: In this role you are required to do analysis and solving of increasingly complex problems Your day to day interactions are with peers within Accenture You are likely to have some interaction with clients and/or Accenture management You will be given minimal instruction on daily work/tasks and a moderate level of instruction on new assignments Decisions that are made by you impact your own work and may impact the work of others In this role you would be an individual contributor and/or oversee a small work effort and/or team Please note that this role may require you to work in rotational shifts BE,BTech,MCA

Perform case intake and data entry into safety databases (e.g., Argus, ArisG). Assist in triaging and prioritizing cases based on seriousness and timelines. Perform quality checks to ensure accuracy and completeness of information. Collect and process adverse event (AE) reports from healthcare professionals, patients, and regulatory authorities Support Periodic Safety Update Reports (PSURs), Risk Management Plans (RMPs), Draft case narratives and perform medical coding (MedDRA). Job Type: Full-time Pay: ₹305,702.54 - ₹565,749.57 per year Benefits: Cell phone reimbursement Health insurance Paid sick time Provident Fund Work Location: In person

Vasta Bio-Informatics Private LimitedMAHARASHTRA Posted On 20 Jun 2025 End Date 31 Jul 2025 Required Experience 1 - 3 Years Basic Section No. Of Openings 2 Grade C1B Designation Clinical Research Associate Closing Date 31 Jul 2025 Organisational Country IN State MAHARASHTRA City NAVI MUMBAI Location Navi Mumbai-I Skills Skill PHARMACOVIGILANCE CLINICAL RESEARCH MEDICAL WRITING ONCOLOGY CLINICAL DEVELOPMENT CRO GCP EDC CLINICAL DATA MANAGEMENT ICH-GCP Education Qualification No data available CERTIFICATION No data available Job Description Job Title: Clinical Research Associate Department: Delivery Job Location: Navi Mumbai Reporting To: Lead Job Duties / Responsibilities: Project and Operations Management- Responsible for the management of designated clinical trials, preparation of trial related documentation per protocol and Case report forms (CRF). Ensure completeness and submission of data into the data collection form (e.g., electronic CRFs, cancer research database (CRDB), PC-based systems, remote data entry) as per protocol requirements and time lines. Tracking completed CRFs and setting up systems whereby completed CRFs are rapidly entered into the database. Ensure that queries generated during cleaning are responded to in a timely fashion and in compliance with ICH-GCP guidelines. Ensure the conduct of the trial is in compliance with the currently approved protocol/amendment. To significantly improve quality assurance and consistency in electronic data capturing and data. Participate in global conference calls and meetings to review progress of ongoing clinical trials. Proficient in the knowledge of protocol monitoring activities. Verify that the investigator followed the approved protocol and all GCP procedures. Communicate any observations to the sponsor i.e. deviations/violations to protocol, safety alerts, quality issues, etc. that may affect the quality of the protocol. Complete regulatory requirements, as applicable. Education and Experience: Bachelors/ Masters Degree with minimum 1 year experience in Clinical Trials Management/Protocols or 0-6 months of experience in Clinical Trials along with certification in Clinical Trials / Research. Knowledge of Oncology Specific terminology preferred. Knowledge of EDCs such as Medidata RAVE, Oracle, Inform, etc. strongly preferred. Experience with Industrial protocols and monitoring visits strongly preferred. Hands-on with computer skills Good communication skills – written and verbal Ability to multitask, work under pressure and meet deadlines required

Job Overview Review, assess and process Safety data and information, across service lines, received from various sources and distribute reports to Regulatory Authorities, Investigative sites, and Ethical committees following applicable Regulations and Standard Operating Procedures (SOPs) and internal guidelines under guidance and support of senior operation team members. Essential Functions To Prioritize and complete the assigned trainings on time. Process Safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements. To perform Pharmacovigilance activities per project requirement including but not limited to, collecting and tracking incoming - Adverse Events(AE)/endpoint information. determining initial/update status of incoming events. Tracking reportable cases and reporting to regulatory authorities as per legislation, within timelines and in a format compatible to requirement. Liaising with local vendors, where applicable, to facilitate expedited reporting. Liaise with different functional team members to address project related issues and successes. Receive and document incoming emails from investigative sites or other sources reporting Lifecycle Safety data. Triage of cases, generate the CTMS list, preparing alert letter package, sending SUSARs to investigators and clinical teams on time, filing the eTMF pack in ELVIS. Ensure to meet quality standards per project requirements. Ensure to meet productivity and delivery standards per project requirements. To ensure compliance to all project related processes and activities. Read and acknowledge all necessary IQVIA standard operating procedures (SOPs) and customer SOPs as required. Ensure all required training is executed in a timely fashion and documented. Work towards ensuring your individual training plan and training transcript are reconcilable. Creating, maintaining and tracking cases as applicable to the project plan. Identify quality problems, if any, and bring them to the attention of a senior team member. To demonstrate problem solving capabilities. Liaise with different functional team members, e.g. project management, clinical, data management health care professionals e.g. investigators, medical monitors, site coordinators and designees to address project related issues. May liaise with client in relation to details on day to day case processing activities. To mentor new teams members, if assigned by the Manager. Attend project team meetings and provide feedback to operations manager on any challenges/issues or successes. Perform other duties as assigned. Lead/ Support department Initiatives 100% compliance towards all people practices and processes Qualifications High School Diploma or equivalent Scientific or healthcare discipline or allied life sciences Req Bachelor's degree in life sciences or related field and 2 years or more experience (Knowledge & Experience Required) on ICSR submission to Regulatory Authorities, Ethical Committees, and Investigative sites. Experience in Clinical Trial and Post Marketed ICSR Regulatory Reporting or any kind or Regulatory Submissions. Experience of “determining and assessing ICSR reportability to various regulatory authorities based on appropriate regulatory intelligence”. Knowledge about concepts of Clinical Trial and Post Market reporting ICH E2B should be beneficial on cross reports across licenses of a pharmaceutical product. Should have experience and knowledge of various formats of ICSR reporting that is submitted to Regulatory authorities, like xml format for EVWEB upload, E2B gateway reporting and transmission, Portal submissions, courier and manual email submissions of CIOMS, MEDWATCH. Experience in ICSR regulatory submission and regulatory guidelines for Drugs/vaccines for various countries. Knowledge of automated and manual scheduling of regulatory reports in safety database. Includes initial report, follow up regulatory report, amendment report scheduling, nullification report, downgrade report. Good knowledge of medical terminology. Working knowledge of applicable Safety Database and any other internal/Client applications. Intermediate. Knowledge of applicable global, regional, local clinical research regulatory requirements. Intermediate Excellent attention to detail and accuracy. Intermediate maintain high quality standards. Intermediate Good working knowledge of Microsoft Office and web-based applications. Intermediate Strong organizational skills and time management skills. Intermediate Strong verbal/written communication skills. Intermediate Self-motivated and flexible. Intermediate Ability to follow instructions/guidelines, utilize initiative and work independently. Intermediate Ability to multi-task, meet strict deadlines, manage competing priorities and changing demands. Intermediate Ability to delegate to less experienced team members. Intermediate Ability to be flexible and receptive to changing process demands. Intermediate Willingness and aptitude to learn new skills across Safety service lines. Intermediate Ability to establish and maintain effective communication and working relationships with coworkers, managers and clients. Intermediate Ability to work as a Team Player, contribute and work towards achieving Team goals. Intermediate Ensure quality of deliverables according to the agreed terms. Intermediate Demonstration of IQVIA core values while doing daily tasks Advanced Extensive use of telephone and face-to-face communication requiring accurate perception of speech. Intermediate Regular sitting for extended periods of time. Intermediate May require occasional travel. Intermediate Flexibility to operate in shifts. 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

Job title : Safety Aggregate Report Specialist 2(Signal Management) Work experience : 3 to 9 years Must have skills : Signal Management and Signal detection Job Overview Apply 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 • 3- 9 years relevant work experience. Pref

Job Description To develop risk-based and Pharmacovigilance (PV) audit program and execute the same within stipulated timelines. To support implementation of the quality strategy, plans for quality improvement and quality assurance initiatives. To prepare for audits and conduct PV internal audits and audits of business partners/ vendors as applicable. To support hosting of Health Authority inspections and external partner audits. To obtain audit responses from internal PV team/subsidiaries and external partners/vendors and evaluate proposed corrections, CAPA for adequacy and appropriateness. Escalate inadequate audit responses to management. To maintain tracker for audit and inspection findings and track compliance for timely completion of Corrective and Preventive Action. To assign Non-Conformances (NC) and Corrective and Preventive Action (CAPA) numbers and review NC information against source documents. To review CAPA implementation documents against source documents and provide feedback on CAPA effectiveness. To ensure that NC/CAPA tracker is maintained as per SOP for inspection readiness and documents are updated. To conduct and close CAPA effectiveness. To support trend analysis of deviations to identify risk areas. To manage, review, tracking and closure of Change Control Requests (CCRs) Work Experience Minimum 10 years in PV of which at least 4 years in QA. Education Graduation Post Graduation in Science or Pharmacy Competencies Innovation & Creativity Process Excellence Developing Talent Stakeholder Management Strategic Agility Collaboration Result Orientation Customer Centricity

Description. Regulatory Associate. 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. Essential Functions. Assists with preparation of product development documents including gap analyses and clinical development plans.. Assists with preparation of regulatory submission documents including components of investigational new drug applications (INDs), new drug applications or new marketing applications (NDAs/MAAs), drug master files (DMFs), variations, renewals, marketing authorisation transfers (MATs) and other lifecycle maintenance activities, according to current government regulations and guidelines.. Conducts regulatory research to identify regulatory precedents and to support the preparation of orphan drug designation requests.. Performs quality checks on related documents.. Assists with submissions of other regulatory documents and other regulatory research as needed.. Assists clients, customers, or others with general information. Gathers, compiles, analyzes, and reports information.. Gathers information, searches files and records, and makes personal contacts to obtain specific information in order to prepare detailed reports and compose routine correspondence.. 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.. Summary. Under supervision, supports regulatory agency submissions, regulatory research, and product development. Responsibilities typically include the creation of submission documents to support investigational new drug applications (INDs), new drug applications or new marketing applications (NDAs/MAAs), drug master files (DMFs), variations, renewals, marketing authorisation transfers (MATs) and other lifecycle maintenance activities.. Show more Show less

Job Title: Local Case Intake Advisor - Global Business Services Career Level - C Introduction to role: Accountabilities: Dive into the world of pharmacovigilance by supporting the processing and handling of ICSRs, including adverse event reporting from clinical and post-marketed sources for AstraZeneca products. Engage with Health Authorities for ICSR-related queries and contribute to the operational implementation of the Quality Management System. Youll manage procedural document management, AE/PV training requirements, quality incident reporting, and audit readiness. Collaborate on PV aspects related to Organised Data Collection Programmes, Digital and Social Media activities, and partnerships with external parties. Provide Patient Safety expertise within the local Marketing company, tackling issue management for key products, risk management, and action plan formulation. Participate in ad-hoc local Marketing Company projects to drive success. Essential Skills/Experience: Degree Qualified - Pharmacy/ Medical/ Science Pharmacovigilance knowledge excellence Good Pharmacovigilance Practice Knowledge of health authority regulations Cross functional collaborative approach Effective and lateral thinking Problem solving Vendor management Excellent attention to detail Excellent written and verbal communication skills Desirable Skills/Experience: Influencing, and Conflict Resolution skills. Medical knowledge in company Therapeutic Areas Project management Successful participation in above-market projects Audit & Inspection experience 19-Jun-2025 19-Jun-2025

ROLE SUMMARY: The medical director provides Clinical Development leadership and expertise on clinical trials, including overseeing the design, conduct, and analysis. The medical director works closely with other functions such as regulatory affairs, pharmacovigilance, biostatistics, and medical affairs to ensure that the clinical development program meets the scientific, ethical, and regulatory standards. The medical director also provides medical expertise and guidance to the clinical operations team, the investigators, and the external stakeholders such as health authorities, ethics committees, and patient advocacy groups. ROLE RESPONSIBILITIES: Study-level Clinical Development Leadership Collaborate with Clinical Scientist(s) to provide clinical leadership across 2-3 study team(s) that is scientifically rigorous and aligns with company objectives. Conduct medical monitoring activities including eligibility assessment, data review and safety monitoring. Lead peer-to-peer interactions with investigators. Serve as the point of contact for clinical issues between the study team, investigators, ethics committees, steering committees, and regulatory authorities. Lead and contribute to development and maintenance of clinical trial and regulatory documents, in collaboration with Clinical Scientist and the cross-functional team. Strategic Guidance, Clinical Insights & Interpretation Collaborate with Clinical Scientist to review and interpret clinical data, identify key findings and implications, and communicate to internal and external stakeholders. Maintains a high level of clinical expertise and professional competence by staying abreast of the latest developments, literature, and guidelines to advise on and drive current and future clinical development plans. QUALIFICATIONS: Medical degree (MD) Relevant clinical or industry experience considered 2-5 years industry experience Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact. NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS Ability to travel to relevant international scientific congresses and internal team meetings 3-6 times per year Work Location Assignment: Hybrid Work Location Assignment: Hybrid At Pfizer we care about our colleagues wellbeing and offer a range of great benefits for them, including: Paid parental leave Access to Health & Wellness apps Career Growth Experiences program Recognition & rewards program Paid volunteer days Life Insurance Benefits Pfizer Learning Academy access to top content providers Access to flu vaccines & skin checks Options to purchase additional leave Salary packaging & novated lease options *Benefits listed may vary depending on your position and location and may be subject to change. Pfizer Australia and New Zealand s diverse workforce represents the patients we serve and the communities in which we operate. With a focus on Diversity, Equity & Inclusion (DE&I), Pfizer ANZ ensures our people are heard and cared for. We offer engagement opportunities in both Colleagues Resource Groups (CRGs) and workstreams across: Culture and Tradition, Reconciliation @ Pfizer (RAP), Gender Equity (GEN), Disability and through the Out Pfizer Employee Network (OPEN) for our LGBT + colleagues and allies. If you require reasonable adjustment during your application, please reach out to the Talent Acquisition Manager. Medical #LI-PFE

Job title: Global Medical expert. Grade: NA. Hiring Manager: Head Scientific Communications/ Team lead. Location: Hyderabad/ Mumbai. % of travel expected: Travel required as per business need. Job type: Permanent and Full time. About The Job. Our Team:. Sanofi Business Operations is an internal Sanofi resource organization based in India and is setup to centralize processes and activities to support Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D, Data & Digital functions. Sanofi Business Operations strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations in Sanofi, globally.. Main Responsibilities. Works with a team of Medical regulatory writers with different levels of expertise, Develops medical expertise within Medical regulatory writing (on contents, methods, and processes). Ensures compliance with regulatory requirements from various regions (FDA, EU others) for activities supported. Coordinates and supports medical activities related to the maintenance of the marketing authorizations of Established and Generic products, in different therapeutic areas. Works in close collaboration with Global Medical Leads, Global Regulatory Affairs, Global Pharmacovigilance, and vendors. Essential Job duties and responsibilities: 1) Responsible to provide a medical assessment with relevant and updated clinical evidence and monitoring the execution of strategic documents such as PBRERs, ACOs, DSURs, Clinical Overviews, Benefit-Risk assessments, Expert statements for MDD, Responses to Health Authority Queries, Ad-hoc literature analyses, and labeling documents for the corresponding therapeutic area or products or any other activities which are the core activities of GMLs. 2) Drafting the extended synopsis of studies in collaboration with RWE experts. He/she will be responsible for overseeing the execution of such plans by the respective operational units in compliance with SOP, GCP, and other regulations. 3) Writing of Key medical/clinical parts of Common Technical Documents (CTD) or Briefing packages (BP). 4) Reviewing and approving compassionate use of individual medical requests for use of Sanofi medicinal products for serious or life-threatening diseases for treatment outside of clinical trials. 5) Secure delivery of high-quality medical documents on time and in compliance with internal and external standards. 6) Collaborates effectively with stakeholders: global medical leads/ medical product leads, global regulatory affairs, medical regulatory writing global or local teams, pharmacovigilance teams, managed access program teams.. People: 1) Maintain effective relationships with the end stakeholders (Medical, regulatory, pharmacovigilance community) within the allocated Global business unit and product – with an end objective to develop medical regulatory content as per requirement, 2) Interact effectively with stakeholders in medical and pharmacovigilance departments 3) Constantly assist the medical regulatory writing team in developing knowledge and sharing expertise. Performance: 1) Secure deliverables (PBRER, ACO, SO, CSR, ID Cards, Investigator brochure, clinical evaluation report, briefing packages, medical section of CTA, CTD, SBRAs, MDD, HAQs or any other activities which are core activities for GMLs) are supported as per agreed timelines and quality. Process: 1) Provide medical strategic insights & evaluation related to Sanofi’s portfolio. 2) Contribute to the management of the marketing authorization dossiers of the current related portfolio. 3) Act as an expert in the field of medical regulatory writing and maintain the regulatory requirement for countries, and teams supported. 4) Assist the assigned medical team in conducting comprehensive medical regulatory writing-needs analysis 5) Implement relevant elements of the medical regulatory plan and associated activities for the year identified for the region 6) Work with selected vendors when required within the region to deliver the required deliverables as per the defined process 7) Assist the head of scientific communications in designing an overall plan of action based on end-customers feedback & improving course content and delivery. Stakeholders: 1) Work closely with medical teams in regions/areas to identify medical writing needs and assist in developing assigned deliverables 2) Liaise with the Medical department to ensure relevant & customized are delivered per expectation. About You. Experience: ?5 years of experience supporting international pharmaceutical companies: medical affairs, clinical development, pharmacovigilance with experience in at least one of the therapeutic areascardiovascular, metabolism, diabetes and lipid, CNS, oncology, anti-infectives, internal medicine. Soft skills: Stakeholder management; communication skills; and ability to work independently and within a team environment. Technical skills: As applicable (Including but not limited to Medical operational excellence, time, and risk management skills, Excellent technical (medical) editing and writing skills). Education: Medical degree MBBS; MD. Languages: Excellent knowledge of the English language (spoken and written). Pursue progress, discover extraordinary. Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!. null. Show more Show less

Description. Regulatory Consultant (Sterile Experience). 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.. Primary. Job Responsibilities. Experience in regulatory submissions for sterile drug products, including aseptic and terminal sterilization processes.. Preparation and review of Module 3.2.P sections related to sterile manufacturing, microbial control, and container closure systems.. Post approval variation experience is mandatory for EU market.. Familiarity with EU Annex 1 requirements and its application in variation, renewal submissions.. Supports in preparation and peer review of regulatory submissions including variations, renewals, and responses to queries.. Handling post-approval changes related to sterile facilities, cleanroom classification, sterilization methods, and equipment upgrades.. Preparation of regulatory assessments and submission strategies specific to sterile dosage forms.. Reviews of media fill protocols, filter validation data, sterility assurance, and cleaning validation documentation for submission readiness.. Provides regulatory support during inspections and audits related to sterile manufacturing.. Change control assessments and preparation of regulatory impact summaries.. Day-to-day execution of tasks in accordance with client SOPs and regulatory standards for high-quality global CMC dossiers.. Collaboration with cross-functional teams including QA, QC (microbiology), validation, technical, analytical, and site functions for data collection and dossier preparation.. Secondary. Acts as a point of contact for coordination of documentation across functional teams to meet submission timelines.. Effective communication through email and calls with internal and client stakeholders for updates and clarifications.. Supports and mentors junior team members depending on project needs.. Hands-on experience with RIMS/Veeva Vault.. Open to working in cross-cultural and virtual team settings.. Qualifications. Minimum 6 years of experience required for regulatory submissions for sterile drug products with Master’s degree in pharmaceutical sciences (preferred) or Master’s degree in other life sciences.. Demonstrated experience in contributing to the preparation of regulatory submissions including, for example IND, PMA, NDA, MAA, and CTD, including electronic submissions.. Excellent interpersonal / communication skills including excellent written and verbal communication skills.. Excellent customer service skills, with the ability to work both as a team member and independently.. Good quality management skills.. Advanced skills in Microsoft Office Applications.. Ability to interact with staff from multiple departments and offices to establish project standards.. Good initiative, adaptability, and pro-activity.. Strong analytical skills, good attention to detail.. Ability to work concurrently on projects, each with specific instructions that may differ from project to project.. Fluent in speaking, writing, and reading English.. 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

Job Description:. Weekly Hours:. 40. Time Type:. Regular. Location:. IND:AP:Hyderabad / Argus Bldg 4f & 5f, Sattva, Knowledge CityAdm: Argus Building, Sattva, Knowledge City. It is the policy of AT&T to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, AT&T will provide reasonable accommodations for qualified individuals with disabilities. AT&T is a fair chance employer and does not initiate a background check until an offer is made.. Show more Show less

We are seeking a highly analytical and strategic Senior Analyst to join our CI team, supporting business-critical decisions across the pharmaceutical product lifecycle.Key Responsibilities:Monitor and analyze competitor activities across pipeline, clinical trials, regulatory, commercial, and corporate developments in assigned therapeutic areas.Synthesize findings into clear, concise, and impactful deliverables such as landscape assessments, competitor profiles, war games, SWOT analyses, and executive briefings.Contribute to CI deliverables supporting brand planning, forecasting, launch readiness, and lifecycle management.Maintain and evolve CI processes, databases, and tools for improved efficiency and insight generation.Present insights to internal stakeholders and senior leadership with strategic recommendations. Qualifications Bachelors degree in a relevant field such as Life Sciences (Pharma, Biotechnology) Job Location

We are a company dedicated to the audit and certification of national and international standards of quality and sustainability in products and processes.. We have an interdisciplinary team of professionals specialized in each industry and sector, committed to providing the highest quality service in a personalized way, generating long-term relationships with our clients and the community.. Our wide service offer, our extensive network of producers, processors and traders, our presence in fairs and seminars in different countries and our growing internationalization, make LETIS a link to the world.. Brief Job Description:. Audit preparation. Audit report preparation. Responding to technical queries.. Sending Audit Packs to Certifying office within stated timeline. Submission of Updated Audit Logs. Technical accuracy as per guidelines of audits packs. Client Satisfaction. Sociable with good market recognition and understanding. Technical Knowledge on the food sector audited. Presentable with the right mix of authority and convincing capability. Analytical capability and prompt decision making capability. Qualifications:. Essential:. Graduate/ Post Graduate in careers related to Agronomy Engineering or registered Rural Administration Technician, etc.;. To have knowledge and skills in organic production and handling techniques. At least 2 years of experience as an organic inspector in another Certifying Body (preferably in NOP regulations). Intermediate-advanced level of English (B2-C1). Desirable:. Food industry work experience with knowledge/ experience in auditing food safety management systems. with good Communication Skills , pleasing personality and proficient in computer usage. Please note it is mandatory to attach an audit log of audits conducted during your career, as well as professional references.. Show more Show less

Description. Regulatory Associate (CMCPre and post approval ). 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. Assists with preparation of product development documents including gap analyses and clinical development plans.. Minimum 2 years of relevant experience. Assists with preparation of regulatory submission documents including components of investigational new drug applications (INDs), new drug applications or new marketing applications (NDAs/MAAs), drug master files (DMFs), variations, renewals, marketing authorisation transfers (MATs) and other lifecycle maintenance activities, according to current government regulations and guidelines.. Conducts regulatory research to identify regulatory precedents and to support the preparation of orphan drug designation requests.. Performs quality checks on related documents.. Assists with submissions of other regulatory documents and other regulatory research as needed.. Assists clients, customers, or others with general information. Gathers, compiles, analyzes, and reports information.. Gathers information, searches files and records, and makes personal contacts to obtain specific information in order to prepare detailed reports and compose routine correspondence.. Qualifications. MS in science/healthcare field, or equivalent combination of education and experience.. Minimum 2 years of relevant experience. Excellent interpersonal / communication skills.. Advanced skills in Microsoft Office Applications.. Good time and project management skills, preferred.. Strong analytical skills and attention to detail.. Ability to work both as a team member and independently and to understand and carry out detailed instructions.. Ability to interact with staff from multiple departments.. Ability to work concurrently on projects, each with specific instructions that may differ from project to project preferred.. Fluent in speaking, writing, and reading English.. 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

While technology is the heart of our business, a global and diverse culture is the heart of our success. We love our people and we take pride in catering them to a culture built on transparency, diversity, integrity, learning and growth. If working in an environment that encourages you to innovate and excel, not just in professional but personal life, interests you- you would enjoy your career with Quantiphi! Role: Associate Engagement Manager (Healthcare & Life Sciences) Experience Level: 6-9 Years Work Location: Mumbai, Bengaluru, Trivandrum Role & Responsibilities: Deliver successful projects across Healthcare and Life Sciences domains, including R&D, Clinical Development, Supply Chain, Quality, Regulatory & Compliance, Healthcare Provider Engagement, Population Health Management, Patient Experience, Digital Health, Marketing, Cost Reduction, Platform Implementation, and Automation. Serve as a Subject Matter Expert (SME) in Healthcare and Life Sciences, providing thought leadership and domain expertise to clients. Collaborate with internal teams and clients to define long-term vision, goals, and strategic roadmaps aligned with healthcare and life sciences priorities. Demonstrate strong consulting and advisory skills, analyzing complex information, synthesizing content, and translating insights into actionable recommendations and deliverables. Implement problem-solving procedures to enhance operational efficiency and effectively resolve client challenges. Develop and implement strategies to maximize customer satisfaction and strengthen client relationships in both healthcare and life sciences sectors. Communicate findings and ideas clearly and persuasively to stakeholders across clinical, operational, and executive levels. Exhibit a strong commercial mindset by optimizing deal pricing, contributing to revenue generation, and driving successful sales outcomes. Support team-building initiatives by recruiting, motivating, and fostering professional growth, with a strong focus on people development. Coach and mentor junior consultants in core consulting skills and healthcare & life sciences domains. Must have skills: 6-9 years of experience in management consulting or relevant roles within Healthcare and/or Life Sciences industries. Proven ability to manage multiple priorities with urgency, drive, and energy. In-depth understanding of healthcare and life sciences industry trends, regulations, and compliance standards. Hands-on experience in one or more of the following areas: Clinical Trials (protocol design, clinical data management, Trial Master File), Pharmacovigilance, Healthcare Provider Engagement, Supply Chain, Manufacturing, Analytics, Quality, Audit/Compliance, Connected Health, Digital Health Platforms. Familiarity with digital architecture, tools, technologies, and products relevant to healthcare and life sciences value chains. Strong analytical and problem-solving skills to decode complex business challenges and propose effective solutions. If you like wild growth and working with happy, enthusiastic over-achievers, youll enjoy your career with us !