875 Pharmacovigilance Jobs - Page 4

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)

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. #LI-REMOTE

Project role : Mgr, Safety Opns Team Work experiences : 7+ years. Work location : Pune/Kolkata/Ahmedabad/Mumbai Mode of work : Office based. Must have skills : Relevant experience in Safety Operations with a minimum of 3 years in line management and over 4 years in Pharmacovigilance (PV). Job Overview Manage Safety staff responsible for Safety Operations processing in alignment with departmental and corporate standards. Contribute to Global initiatives. Work in close collaboration with SM and other relevant stakeholders supporting the achievement of local and global deliverables and metrics. Job Responsibilities: Work closely with operations specialist managers. Work with Safety Management constructively in a matrix framework to achieve project and customer deliverables. Hold at least bi-monthly meetings with direct reports to discuss, at a minimum: project status, including timelines, delivery updates, financial aspects of the group or project, and potential risks, associated mitigation and support required; status of any initiatives that they may be involved in; the team's utilization rates; the direct report's training and other administrative obligations, such as Standard Operating Procedures (SOPs) and corporate training mandates; personnel issues; and career or training objectives. Develop and implement plans for measuring and improving employee engagement, ensuring global consistency. Collaborate with project leads to address work scheduling for current and projected projects, staffing needs, technological needs, and projected peak workloads, ensuring global consistency, where possible. Develop and manage associated action plans to hold members accountable. Efficiently conveying messages from leadership to direct reports and teams, as well as effectively communicating issues and opportunities up to leadership. Might be needed to serve as the designated substitute or alternatively ensure coverage is in place for direct reports during their absence or in case of turnover. Attend and participate in Bid Defenses, Kick off Meetings (KOM), as applicable. Support Request for Information (RFI), Request for Pricing (RFP), and budgets, as requested Participate / Support internal and external audits and inspections, as required. Also ensure required staff is assigned, trained and prepared to support. Qualifications required: Bachelor's Degree Scientific or healthcare discipline or allied life sciences Req Bachelor's degree in life sciences or related field and up to 7 years of relevant experience, inclusive of up to 4 years of PV experience and up to 3 years of Line management experience. Req or equivalent combination of education, training, and experience. Other skills: Flexibility to operate in shifts. In-depth knowledge of Safety service lines. Willingness to increase knowledge across Safety service lines and develop new skills. Proven Staff management skills, strong leadership, motivational and influencing skills. Strong organizational skills, metrics calculations, and time management skills. Strong verbal/written communication skills Ability to work on multiple projects and manage competing priorities effectively. Effective mentoring and developed coaching skills. Ability to achieve results through proactive communication and facilitation in a matrix service delivery environment with shared accountabilities. Sound judgment, decision-making and problem-solving skills. Ability to establish and maintain effective working relationships with coworkers, managers, and clients. Ability to follow instructions/guidelines, utilize initiative and work independently. Understanding on basic Project Finance (EAC, forecasting, burn-rate monitoring and recognizing & pursuing OOS where appropriate) Ability to drive business and financial results – short and long term. Ability to proactively evaluate risks and potential issues and seek solutions and discuss appropriately with direct reports, colleagues, and customers Demonstrates good judgement in requesting input from senior staff. When requesting input, ensure clearly laying out the issue and required background details, articulating what support is needed; and what are the recommended actions. Show more Show less

Job description : Lead the preparation and review of aggregate safety, risk management, signal detection, and benefit-risk evaluation reports Demonstrate the ability to independently manage the production of safety deliverables, including those involving complex data analyses or important safety issues Act as a technical lead of the medical writing teams across projects and provide guidance and expertise for developing high-quality scientific content as required for various safety deliverables Establish good client communication and coordination within writing teams to manage stakeholder expectations and resolve any issues surrounding project/report deliverables Contribute to scientific publications and represent the company at scientific meetings and conferences Work with the project management team to implement quality and process improvement initiatives Foster excellent working relationships with all clients, both internal and external, with the highest quality of service in a cost-effective manner on time, every time. Summary of Responsibilities: Write and review various safety reports for global regulatory submissions for clients, including but not limited to Annual Reports (IND and other), Periodic Safety Update Reports, Periodic Adverse Drug Experience Reports, Development Safety Update Report, Clinical Overviews, Medical Device reports, and other documents as assigned. Lead the end-to-end process of report production and ensure the required quality standards and key timelines are met. Provide oversight to co-authors or team of writers as applicable and be accountable for the quality of their work/contributions. Act as the primary point of contact for the client for all report management activities. Engage in client communication to manage stakeholder expectations, present anticipated challenges, propose remediation, and escalate unresolved issues impacting deliverables at an individual report or project level. Author/review RMPs, ad hoc reports, Benefit-Risk Evaluation reports, supporting documents for label updates, reports of effectiveness of risk minimization measures or enhanced pharmacovigilance activities. Lead/participate in various steps of the signal management process. Provide inputs for developing signal strategies and retrieval of data from safety databases, scientific literature, and other sources, as required. Author/review signal evaluation/management reports (ad hoc and periodic) and safety issue analysis reports. Participate in safety/benefit-risk review meetings with clients, discuss results and conclusions from signal/safety analysis, and in collaboration with the safety physician, propose label updates and other risk mitigation measures, as needed. Draft responses (or parts thereof) to health authority questions or feedback and collaborate with cross functional stakeholders in the management and tracking of such feedback. Develop abstracts, posters, manuscripts, and other documents for scientific publication or presentation at conferences or pharmacovigilance forums. Prepare medical information responses for HCPs. Act as a writing coach, provide regular quality feedback, conduct training, and share best practices with associates for promoting the use of clear and concise writing and adherence to style guides, as applicable. Support project management activities such as maintenance of project schedules and tracking of metrics and compliance. Contribute to business development activities, including estimation of resource requirement and responding to RFPs. Create and update labels, e.g. Core Data Sheets, USPI, centralized SPC s, Med Guides. Conduct literature reviews, formulate and execute search strategies, including those for complex topics or research questions. Implement and promote use of consistent, efficient, and quality processes to meet timelines and deliverables according to requirements and standard operating procedures and assume accountability for the deliverables. Ensure compliance of operations with governing regulatory requirements. Create, maintain, and assume accountability for a culture of high customer service. Perform any additional activities per project requirement or at the manager s discretion upon completion of relevant training. And all other duties as needed or assigned. Qualifications (Minimum Required): Minimum of first degree in life sciences (or equivalent). Fortrea may consider relevant and equivalent experience in lieu of educational requirements. Experience (Minimum Required): At least 5-7 years of experience in the pharmaceutical industry, with at least 4 years of it in medical writing. Excellent command of written and spoken English. Good written and verbal communication skills. Knowledge of MS Office. Good organizational and time management ability. Excellent interpersonal and leadership skills. Scientific or clinical research or medical writing experience desirable. Good understanding of regulatory requirements, good Pharmacovigilance practices and ICH GCP guidelines.

We are looking for an MSL- Oncology for a Global Pharmaceutical MNC Profile: Medical Science Liaison- Oncology Location: Delhi/ Kolkata (2 openings) Qualification: MD Pharmacology with minimum 6 months of experience in solid cancers MDS/ PhD with minimum 1yr of Oncology experience as MSL/RMA MD Pharmacology with clinical experience in Oncology can apply too Job Purpose: The Medical Science Liaison (MSL) will establish the company’s medical affairs presence with external stakeholders through scientific exchange and research support in oncology. The focus will be on licensed and non-licensed products for hard-to-treat cancers, including metastatic pancreatic cancer, cholangiocarcinoma, digestive cancers (such as stomach cancer, pancreatic cancer, and cholangiocarcinoma), glioma, brain tumors, hematologic cancers (acute myeloid leukemia, acute lymphoblastic leukemia, and lymphoma), and pediatric cancers. This role is field-based, covering the India region. The MSL will communicate balanced therapeutic area-related, product-related, and clinical information to external stakeholders (e.g., physicians, academic institutions, hospital formulary committees), respond to unsolicited requests for medical information, facilitate research discussions, and bring key insights from the medical and scientific community to internal stakeholders. The role also involves ensuring compliance with all company procedures, confidentiality standards, and contributing to business success with a focus on patient safety. Principal Accountabilities: 1. Exchange of Medical and Scientific Information: Responsible for communicating fair and balanced therapeutic area-related, product-related, and clinical information to external stakeholders. Execute the scientific engagement plan in alignment with the Therapy Medical Plan. Proactively develop long-term peer-to-peer relationships with opinion leaders and relevant stakeholders. Respond to unsolicited requests for medical information, including off-label data, related to marketed products and pipeline products. Provide clinical and medical presentations to external stakeholders as needed. Disseminate updates from scientific meetings and report information of strategic interest to cross-functional teams. 2. Supporting Clinical Research: Support ongoing and future Medical Affairs Company-Sponsored Studies, providing country-level review of proposed research site lists, attending site visits if necessary, and providing feedback to the line manager. Support unsolicited requests for investigator-initiated trials (IITs) proposals by offering appropriate investigator support as per company SOPs. Assist in the development and support of national disease registries and Real-World Evidence (RWE) projects as necessary. 3. Contributing to the Organization through Medical Expertise & Market Insights: Maintain up-to-date knowledge of scientific/medical developments in the relevant therapeutic area through literature searches, clinical papers, conferences, and other relevant events. Capture and share in-field insights to develop territorial Field Medical Plans and support medical and scientific strategies. Provide medical and scientific expertise to commercial partners within regulatory guidelines. Act as a field-based scientific and clinical reference for internal stakeholders (e.g., sales, market access) through training and ad-hoc support. 4. Cross-Functional Collaboration: Support the development of medical/scientific materials, ensuring content is reviewed and approved according to company policies. Contribute to the development and execution of the regional medical affairs strategy and action plan in collaboration with field departments such as Sales, Clinical Research, and Market Access. Keep medical representatives and their managers informed about the latest scientific developments. Support the market access strategy at a regional level, including hospital listings, in coordination with the market access manager. 5. Compliance with External Regulations and Company Policies: Maintain a high level of scientific, clinical, and environmental knowledge through courses, self-learning, and attendance at relevant meetings. Stay informed about regulations related to medical information services in the pharmaceutical industry. Ensure all activities comply with internal and external codes of conduct, prioritizing patient safety by following pharmacovigilance processes. Support the company’s reputation in the field by adhering to industry regulations. 6. Patient-In Activities: Support patient awareness initiatives, both physical and digital. Contribute to the Patient-In strategy, understanding the patient journey in coordination with therapeutic area experts, and set up Patient Support Programs (PSPs) to improve patient outcomes as per local regulations. General Administration: Complete all required administration within the specified timelines. Submit monthly reports and expenses by the second working day of each month. Ensure timely completion and submission of all required documentation to the Head Office as appropriate. Profile Requirements A] Minimum Requirements: Education: MBBS/MD Minimum 1-2 years of working experience in oncology. B] Indispensable Qualities: Strong ability to learn new subjects and environments comprehensively. Excellent written and spoken communication and presentation skills, with the ability to build and maintain collaborative relationships with opinion leaders, physicians, and other healthcare decision-makers. Substantial business acumen and autonomy in managing priorities and activities. Strong commitment to compliance with relevant rules and procedures, as well as scientific integrity and quality. Ability to manage cross-functional projects effectively. Leadership skills, emotional intelligence, active listening, and strength of conviction. Negotiation and problem-solving abilities. Proficiency in English is essential. Ability to innovate and execute strategies effectively. Relevant candidates can share their CV at pooja.j@domniclewis.com Show more Show less

TCS is hiring for Pharmacovigilance Associate!!! Job Location: Mumbai Experience Range: 1 to 6 Years Educational Qualification(s) Required: BPharm, BSc, MPharm, MSc, BAMS & BDS Interested candidates are requested share updated CV with below details on the mentioned mail id – babeeta.shahi@tcs.com Immediate Joiner Can consider only First Name- Middle Name- Last Name- Contact No.- Email ID- Current Org- Education- University Name- Total Exp- Relevant Exp in PV- Current CTC- Expected CTC- Notice Period - Current Location- EPCN/Pan Card No. (If EPCN is not created, please share PAN no.)- Are you ok to work in night shifts Do you have any GAPs in your education & employment (Pls mention the GAP- Yrs/Months) - Thanks & Regards, Babeeta shahi Sourcing Specialist HR- Corporate Talent Acquisition Group Show more Show less

Primary responsibilities 1.Medical monitoring of the in-house clinical trials and overseeing of CRO medical monitoring of outsourced projects 2.Development and review clinical documents including protocol, investigator's brochure, case record form, product rationale, prescribing information, drug interactions etc 3.Organization of Subject Expert Committee meeting materials and attending SEC meetings for clinical trials and marketing approvals Secondary responsibilities 1.Medical Review of ICSRs, Aggregate reports, Signal reports and Risk Management plans 2.Review of clinical and non-clinical overviews and summaries of CTD 3.Review of medical rationale for CT waiver applications 4.New products evaluation for development 5.Develop, review and approve marketing requests of product evaluations, comparative safety and efficacy training material 6.Mentoring/ training team members to gain required skills to enable on-time deliverables.

Minimum of 8 years experience in handling Aggregate reports such as PBRERs/PSURs, PADERs, RMP and Signal Management reports. To lead the aggregate reporting team, and to schedule and ensure regulatory compliance in preparation, review and reporting of aggregate reports (PADERs andPBRERS/PSURs), signal reports, risk management plan reports. To oversee the assignment of activities within the team and ensure the timely delivery and appropriate quality oversight of aggregate reports. Ensure tasks are performed as per applicable procedures (e.g., WI, SOPs) assigned to the role. To provide response to the regulatory queries on safety topics and relevant documents in support to content of safety. Qualification: M. Pharmacy/Pharm D

Skill required: Clinical Data Services - Clinical Data Management Designation: Clinical Data Svs Sr Analyst Qualifications: Bachelor of Pharmacy/Master of Pharmacy 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. A critical phase in clinical research that assures collection, integration and availability of data at appropriate quality and cost. It also supports the conduct, management and analysis of studies across the spectrum of clinical research as defined by the National Institutes of Health (NIH). What are we looking for? Ability to establish strong client relationship Ability to handle disputes Ability to manage multiple stakeholders Ability to meet deadlines Ability to work well in a team 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 Bachelor of Pharmacy,Master of Pharmacy Show more Show less

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

Job Description Summary :- Responsible for management of scheduled and unscheduled aggregate reports including but not limited to Periodic Safety Reports (PSRs) including Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), Addendum to Clinical Overviews (ACOs), Semi-Annual Safety Reports (SASRs), Corporate Addendum Reports, United States Periodic Adverse Drug Experience Reports (PADERs), Development Safety Update Reports (DSURs), Annual Risk-Benefit Evaluation (ARBE) report, Risk Management Plan (RMP), Safety statements, Health Hazard Evaluation (HHE), Drug Safety Report (DSR), Clinical Overview (CO), Safety Evaluation Report (SER), Investigational New Drug Annual Report (INDARs) as well as preparing document of comparison between local and global labeling document (if applicable) and checking of International Non-proprietary names (INNs) for inclusion in a PSR as per client requirements and signal detection and management (where applicable). Generating Line Listings, creating drug lists/drug folders, performing regulatory submissions, tests electronic submissions gateways, and tracking compliance monitoring of submissions in accordance with client/international conventions Responsible for preparing the narratives associated with the client’s/sponsor’s products from clinical trials for Clinical Study Reports (CSRs) or in order to support any health authority requests in accordance with regulatory and client’s/sponsor’s requirements Scheduling and Attending meetings/ Drafting meeting agenda and minutes/Tracking action items. Job Description:- Preparing/updating/merging RMPs/Company Core-RMPs (CC-RMPs), preparing a health authority response document along with RMS update in accordance with client requirements/conventions and SOPs. Managing scheduled and unscheduled aggregate reports including but not limited to Periodic Safety Update Reports (PSURs), Periodic Benefit Risk Evaluation Reports (PBRERs), Addendum to Clinical Overviews (ACOs), Semi-Annual Safety Reports (SASRs), Corporate Addendum Reports, United States Periodic Adverse Drug Experience Reports (PADERs), Development Safety Update Reports (DSURs), Annual Risk-Benefit Evaluation (ARBE) report, Safety statements, Health Hazard Evaluation (HHE), Drug Safety Report (DSR), Clinical Overview (CO), Safety Evaluation Report (SER), Investigational New Drug Annual Report (INDARs), comparison document between local and global labeling document (if applicable)and checking of International Non-proprietary names (INNs) for inclusion in a PSR as per client requirements and conventions and SOPs Conducting critical appraisal and systematic review of literature with a focus on background epidemiology, specifically information on the incidence, prevalence and risk factor in patient populations, for inclusion in drug Safety Reports and RMPs Providing input and developing literature search strategies for the epidemiology section of safety reports Applying epidemiological methods and calculations to data available in literature to support the background rates of the issues under evaluation for the safety reports Generating Line Listings for submissions/ to identifying discrepancies and ensuring resolution of the discrepancies Revising document drafts based on the review comments from team members to ensure inclusion of all relevant input. Ensuring that all work is complete and of high quality prior to team or client distribution. Confirm data consistency and integrity across the document. Performing aggregate report compliance activities including quality review to check the data/facts and internal consistency across various type of aggregate reports including but not limited to PBRERs, Ad hocs, HHEs, LJDs, tables, RMP, Pharmacovigilance System Master File (PSMF) document (as applicable). Distributing of final reports to the stakeholders including partners, affiliates and submission to health authorities, according to the agreed timelines, distribution lists and email templates (as required). Scheduling and Attending meetings/ Drafting meeting agenda and minutes/Tracking action items. Show more Show less

Location: Begumpet, Hyderabad Shift: 6:30 PM - 3:30 AM IST | 8 hours/day | 40 hours/week Company: Synectics Why Synectics? Synectics partners with Fortune 500 companies across industries, offering a fast-paced, collaborative environment where your work makes a real impact and supports your career growth. Role Overview You will identify and place top talent across pharmaceutical and clinical roles, working closely with hiring managers and MSP/VMS contacts to deliver tailored staffing solutions in life sciences, healthcare, and biotech. Key Responsibilities Manage end-to-end recruitment for pharma and clinical roles Use MSP and VMS platforms to handle requisitions and client needs Collaborate with hiring managers to understand roles and develop sourcing strategies Source candidates via LinkedIn Recruiter, job boards, referrals, and internal databases Screen candidates, coordinate interviews, and support offers Maintain accurate records in ATS and build a strong candidate pipeline Requirements 2-3 years' experience in pharma/clinical recruitment, preferably within MSP/VMS environments Strong knowledge of clinical trials, FDA regulations, and industry roles Experience recruiting for Clinical Research, Regulatory Affairs, QA, Pharmacovigilance, etc. Proficiency with ATS, VMS tools, and sourcing technologies Excellent communication, organization, and multitasking skills Self-motivated with the ability to work independently in a high-volume environment Why Join Us? Performance-based incentives Healthcare benefits after initial period Work with Fortune 500 clients in life sciences Collaborative culture focused on continuous learning Show more Show less

Role Regional Managing Partner - Deputy Vice President, Kotak Agency - Field Sales (L7) Experience 6-12yrs. Job Role Recruitment Parameters -Increasing Distribution through Coding of new Partners & increasing LA base -Pragati Promotion -SAP / CAP Creation -Partner Promotion -Handhold & Coach Distribution for Recruitment -Minimum Distribution Criteria of 8:80 Business Parameters -Meet the budgeted business numbers -Maintain minimum Persistency of 85% -Coach & Train Agency to work Independently & Digitally -Meet the CLA numbers -Initiatives to improve Partner Income -Periodic meeting of Partners & Las -Support Agency with all relevant report & MIS Primary Responsibilities External Relations Internal Relations Educational qualifications preferred Category Bachelor's Degree

Hi We are hiring for Leading ITES Company for Clinical Data Manager Profile. Role & responsibilities: Candidate should have 2-5 years of experience of CDM with experience in Conduct Scope of work Perform day-to-day Clinical Data Management activities. Experience in doing external data reconciliation Work and coordinate with the team to perform data management activities and deliver an error-free quality database in accordance with the data management plan and regulator standards. Read and understand the study protocol and the timelines. Perform test data entry in the TEST environment, data listing review, data reconciliation, and query management tasks. Escalate/Action discrepancy in the clinical data as appropriate. Perform external checks to handle manual discrepancies and action the same. Ensure an error-free, quality data with no open queries. Escalate any discrepancy in the clinical data to the study lead as appropriate. Timely completion of training Any other tasks deemed appropriate To perform medical data collection and analysis of Prostate Cancer Data using databases like HIS/ EMR (Electronic Medical Record) and Caisis, Rave, CDM (startup, closeout, conduct) Client interaction and meetings. Bringing up new ideas and executing new plans to cope with the backlog. Training new team members as and when required. To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Mumbai ) Type : Job Code # 205 b) To Apply for above Job Role ( Pune ) Type : Job Code # 206 c) To Apply for above Job Role ( Bangalore ) Type : Job Code # 207

SUMMARY Job Title: SAR & SAR-like Patient Safety Physician Reporting To: Patient Safety Physician SAR & SAR-like Coordinator Minimum Educational Qualifications and Experience Required Skills Proficient in delivering presentations Effective at collaborating across different cultures Strong preference for structured and process-driven tasks Committed to completing training and documentation on time Operational Responsibilities Compile PBRERs with a focus on medical aspects and safety sections of products, and analyze safety trends, including source data analysis based on queries Assist in identifying, analyzing, and drawing conclusions from safety data for cumulative trends Collaborate with Therapeutic Head to identify signals and address product safety concerns Engage with Therapeutic Area colleagues for enhanced understanding and development Measurable Goals Ensure 100% compliance with timely completion of all client and Cognizant required trainings Achieve 100% compliance with work allocation plan, including case closure based on agreed timelines and quality benchmarks Non - Measurable Attributes Self - motivated Goal-oriented Interdepartmental collaboration Personal grooming and etiquette Punctuality Team player and process-oriented Requirements Requirements: Relevant educational background and experience in patient safety or related field Strong presentation and communication skills Effective intercultural work capabilities Commitment to timely completion of tasks and documentation Analytical and problem-solving skills Collaboration and teamwork abilities

Position Purpose: Review, preparation, and completion of reports of adverse drug experiences, to determine the safety profile of Pfizer s products and to meet regulatory requirements. Primary Responsibilities: Identify and select routine cases for processing, determining appropriate prioritization criteria, and noting reasons for any delays. Assess cases to distinguish those with particular complexities and/or specific issues, and escalate appropriately. Review, rank, verify, process and document: event terms; case classifications (validity, seriousness, expectedness / listedness / labeledness); special scenarios; product complaint information; reportability with due date; and accuracy and consistency. Based on assessment of cases, process accordingly. Review case criteria to determine the appropriate workflow for case processing. Write and edit the case narrative. Generate reports, ensuring adherence to regulatory compliance timelines. Determine appropriate case follow-up, requesting follow-up letters when appropriate. Liaise with key partners, including Pfizer Country Organizations, Clinical Development, License Partners, and other stakeholders regarding safety data collection and data reconciliation. Develop and maintain expertise and knowledge of all products within the Pfizer portfolio; applicable corporate and global regulations, guidelines, Standard Operating Procedures and writing practices; data entry conventions; and search functions in the safety database. Consistently apply regulatory requirements and Pfizer policies. Qualifications (i. e. , preferred education, experience, attributes): Masters degree in healthcare profession (ie, Pharmacy, Dentistry, Nursing etc). 1-3-years experience in pharmacovigilance/ related domains. Work Location Assignment: Hybrid Medical #LI-PFE

6 montt to 1 year for pharmacist 1 to 2 year for non pharmacist Dispense prescription and over-the-counter medications accurately Provide appropriate medication counseling and drug usage instructions Maintain proper storage mngt Required Candidate profile Check prescriptions for accuracy and possible drug interactions Ensure compliance with medical and pharmacy regulations Maintain pharmacy records as per statutory requirements

Job Title: Good Clinical Practice (GCP) QA Reports To: Associate Director/Director- GCP QA Employment Type: Full-time Workplace Type: Remote Timings: Flexible (Upto 2 am IST, few times a week) Travel : International Travel Required (15-45 days duration) THE CELITO TEAM The Celito Team architects the buildout of simplified, integrated, and compliant technology stacks. With both consulting and products, our expertise can help our customers save time and money as they move from strategic Clinical & Quality management all the way to widespread and profitable commercialization. JOB OVERVIEW We are seeking a highly skilled and experienced Senior Manager or Manager of Good Clinical Practice (GCP) Quality Assurance to join our team. This role is responsible for conducting GCP audits, providing consultations, and supporting clinical trial activities for our Research and Development (R&D) division. This role will involve strategic planning and implementation of GCP principles, supporting inspection readiness activities, and leading the Quality Management System (QMS) initiatives. The ideal candidate will possess significant decision-making authority on clinical quality matters and ensure the efficient operation of the QA department. KEY RESPONSIBLIITIES Conduct GCP Audits and Provide Consultations: • Perform on-site and virtual audits of clinical investigator sites, processes, documents, and vendors including CROs, central labs, IVRS, and data management. • Offer expert consultations and clinical trial support to R&D teams. Serve in an Advisory Role for R&D: • Advise Clinical Operations, Clinical Development, Statistics, Programming, Regulatory Affairs, Pharmacovigilance, and other R&D functions. • Review and provide feedback on clinical documents including protocols, consent forms, monitoring plans, and data management plans. Quality Assurance Activities: • Oversee quality assurance activities related to clinical, bioanalytical, diagnostic, safety, and pharmacokinetics analyses of clinical studies. • Ensure all activities comply with GCP guidelines and regulatory requirements. Lead GCP Inspection Readiness Activities: • Prepare for and lead GCP inspection readiness activities, including preparation, hosting, and responding to findings from regulatory inspections. • Develop and implement strategies to maintain continuous inspection readiness. Decision Making on Clinical Quality Matters: • Exercise significant decision-making authority on clinical quality matters, including addressing serious GCP breaches. • Provide guidance and recommendations for resolving quality issues. Support Quality Management System (QMS): • Author and review Clinical Quality Assurance (CQA) Standard Operating Procedures (SOPs). • Review and ensure alignment of functional area SOPs with GCP and regulatory standards. Collaboration and Communication: • Work closely with cross-functional teams to ensure alignment and compliance with GCP. • Provide training and mentorship to team members on GCP and quality assurance practices. Continuous Improvement: • Identify areas for improvement in clinical processes and practices. • Develop and implement corrective and preventive actions (CAPAs) to enhance quality and compliance. Leverage International Experience: • Utilize extensive experience working with US and European companies to navigate and comply with varying regulatory requirements. • Facilitate global clinical trials and ensure adherence to multinational GCP standards. QUALIFICATIONS • Master’s or bachelor’s degree in a relevant field (e.g., Life Sciences, Pharmacy, Medicine). An advanced degree is preferred. • 12- 15 years of experience in clinical research quality assurance or a related field. • Extensive knowledge of GCP guidelines and regulatory requirements. • Proven experience in conducting GCP audits and inspections. • Strong analytical and problem-solving skills. • Excellent communication and interpersonal skills. • Ability to work independently and as part of a multidisciplinary team. • Certification in GCP or related areas is a plus. • Extensive experience working with US and European companies. Show more Show less

Analysts engage in risk, compliance, and financial crimes projects to serve Promontory clients within the banking and finance industry – helping them meet and exceed regulatory expectations. Analysts are expected to positively contribute to Promontory’s success in a variety of areas, including BSA, anti-money laundering surveillance and reporting assistance, OFAC sanctions compliance, and other areas relevant to today’s heightened regulatory climate. Analysts must possess excellent writing, research, analytical, and critical thinking skills, and other applicable experience that leads to success in the role, such as strong work ethic and natural curiosity. Analysts must be able to judiciously analyze, assess, and write clearly and concisely. The nature of this work requires individuals to be flexible, learn new skills, work within time constraints, and meet uncompromising quality requirements and production expectations while working closely with others in a dynamic team environment. Apply logic and strong reasoning skills to conduct research for case analysis. Use sound decision-making skills to make recommendations based on research results. Compose comprehensive supporting narratives Interpret and apply project policies and procedures to direct work. Maintain high work product quality as outlined by each project specifications. Ensure work adheres to defined engagement policies and procedures Manage work efficiently to meet production goals and project deliverables. Contribute to developing individual and project goals and execute on tactical strategies for goal attainment. Required education Bachelor's Degree Preferred education Master's Degree Required technical and professional expertise 1+ year prior AML experience REQUIRED. Compliance experience at a financial institution is STRONGLY PREFERRED. Retail banking experience is PREFERRED. The ability to work independently, take initiative, and able to adapt to change. Ability to quickly understand and maintain current know3ledge of banking regulations, concepts, and issues. Quickly learn new applications and client systems to conduct research. Exercise sound judgment and observe the highest degree of confidentiality. Adept at multi-tasking and meeting deadlines in high-pressure environment. Results oriented team player with strong initiative and flexibility. Strong analytical and problem-solving abilities. Superior writing skills with the ability to convey ideas clearly and succinctly. Exemplary customer service towards both internal and external parties.

Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Specialist Qualifications: MBBS/MD Years of Experience: 3 to 5 years Language - Ability: English(International) - Proficient About Accenture 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 worlds 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. Visit us at www.accenture.com What would you do Performs Medical Assessment activities related to drug safety Pharmacovigilance for the Individual Case Safety Reports- Responsible to perform Medical Review of ICSRs according to the client SOPs/Manuals- Prioritizes the cases according to Regulatory clock date, Seriousness criteria and ensure the cases are completed according to the timelines mentioned in client SOP- Performs review of all applicable Medical Review Fields and ensures accuracy - Plan, organize and manage daily work to meet the service level timelines and deliverables- Review MedDRA coding of reported terms in Cases, suggest additional events to be added wherever necessary - Causality assessment of serious cases and relevant non-serious cases with Company Remarks wherever applicable- Performs labelling of events of applicable cases- Provides Medical Expertise to case processing team whenever required- Provides training/mentoring to the team members wherever applicableCreate and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. What are we looking for Understanding of PharmacovigialnceExperience in Medical Review of ICSRsMedical Review Roles and Responsibilities: - Responsible to perform Medical Review of ICSRs according to the client SOPs/Manuals- Prioritizes the cases according to Regulatory clock date, Seriousness criteria and ensure the cases are completed according to the timelines mentioned in client SOP- Performs review of all applicable Medical Review Fields and ensures accuracy - Plan, organize and manage daily work to meet the service level timelines and deliverables- Review MedDRA coding of reported terms in Cases, suggest additional events to be added wherever necessary - Causality assessment of serious cases and relevant non-serious cases with Company Remarks wherever applicable- Performs labelling of events of applicable cases- Provides Medical Expertise to case processing team whenever required- Provides training/mentoring to the team members wherever applicable Qualification MBBS,MD

OVERVIEW: The Junior Pharmacovigilance Specialist collaborates with the PV Solutions production team to analyze and report on safety parameters, within the context of patient safety against our clients’ products, and in line with client requirements for case review. DESCRIPTION: Perform various tasks in support of our clients’ clinical research including adverse event analysis and processing Prepare safety reports for submission to various health authorities Maintain data integrity and promote audit compliance by following Good Documentation Practice (GDP) standards Adhere to project timelines, with proactive communication with Team Lead and Project Managers, as needed Understand and comply with appropriate conventions and other governing bodies following applicable divisional guidelines, templates, and Standard Operating Procedures (SOPs) Analyze stakeholder complaints related to safety reporting, address in real time, and discuss with Project Managers to mitigate risk and implement/drive solutions Complete all other tasks that are deemed appropriate for this role and assigned by the manager/supervisor REQUIRED SKILLS: Knowledge of Common Toxicity Criteria (CTC) and/or MedDRA coding Knowledge of Good Clinical Practice (GCP), Good Documentation Practice (GDP), and International Conference on Harmonization (ICH) guidelines Proficiency in Word, PowerPoint, Excel, Outlook, EndNote, and scientific databases including PubMed, Embase, etc. Excellent written and oral communication skills in English Strong attention to detail and adherence to SOPs and client specifications REQUIRED EXPERIENCE AND QUALIFICATIONS: Minimum Bachelor's degree in pharmacy or Master degree in Life Science Experience (Preferred but Not Mandatory) 1+ year in Pharmacovigilance (for experienced candidates). Medical or healthcare-related experience is a plus Recent graduates with a strong academic background and interest in drug safety/pharmacovigilance are encouraged to apply Ability to work in collaborative, cross-functional teams (internships/academic projects may be considered) DESIRED SKILLS AND EXPERIENCE: Drug development/clinical trial knowledge Creative thinker – Curious and unafraid to ask questions Hard worker – Industrious and diligent in everything you do Innovator – Willing to initiate changes and introduce new ideas Team player who collaborates effectively Show more Show less

About Pacifix Research: Pacifix Research is a leading training and placement institution specializing in Clinical Research, Medical Coding, Pharmacovigilance, and related healthcare training programs. We’re passionate about preparing our students for rewarding employment opportunities in the healthcare industry. Job Description: We are looking for a freelance Medical Coding Trainer (Should be CPC Certified) to join our team and deliver high-caliber training sessions for our students. As a CPC trainer, you will be responsible for: ✅ Providing training sessions (online / offline) to prepare students for the CPC certification exam. ✅ Designing training material and practice exams. ✅ Providing guidance, clearing doubts, and mentoring students toward successfully obtaining their CPC credentials. ✅ Staying updated with the latest coding guidelines and industry practices. ✅ Assessing student progress and offering constructive feedback. Requirements: ✨ CPC certification (AAPC) is mandatory. ✨ At least 2–3 years of coding experience. ✨ Prior training or teaching experience is a plus but not required. ✨ Ability to explain complex coding concepts in a clear and simple way. ✨ Excellent communication skills (English). ✨ Reliable internet connection for conducting online sessions. ✨ Flexible hours (depending on batches). Compensation: ✅ Competitive pay (depending on experience). ✅ Flexible freelance schedule. ✅ Opportunity to collaborate with a growing training institution. How to Apply: If you’re passionate about mentoring future coding professionals, please apply through Indeed with your updated resume or portfolio. We look forward to welcoming you to our team at Pacifix Research! Job Types: Part-time, Permanent, Fresher Pay: ₹20,000.00 - ₹25,000.00 per month Expected hours: 10 per week Schedule: Evening shift Monday to Friday Education: Bachelor's (Preferred) Experience: medical coding trainer: 1 year (Preferred) License/Certification: CPC (Preferred) Work Location: In person Expected Start Date: 01/07/2025

Wipro Limited (NYSE: WIT, BSE: 507685, NSE: WIPRO) is a leading technology services and consulting company focused on building innovative solutions that address clients’ most complex digital transformation needs. Leveraging our holistic portfolio of capabilities in consulting, design, engineering, and operations, we help clients realize their boldest ambitions and build future-ready, sustainable businesses. With over 230,000 employees and business partners across 65 countries, we deliver on the promise of helping our customers, colleagues, and communities thrive in an ever-changing world. For additional information, visit us at www.wipro.com. Job Description Role Purpose The purpose of the role is to provide effective technical support to the process and actively resolve client issues directly or through timely escalation to meet process SLAs. ͏ Do Support process by managing transactions as per required quality standards Fielding all incoming help requests from clients via telephone and/or emails in a courteous manner Document all pertinent end user identification information, including name, department, contact information and nature of problem or issue Update own availability in the RAVE system to ensure productivity of the process Record, track, and document all queries received, problem-solving steps taken and total successful and unsuccessful resolutions Follow standard processes and procedures to resolve all client queries Resolve client queries as per the SLA’s defined in the contract Access and maintain internal knowledge bases, resources and frequently asked questions to aid in and provide effective problem resolution to clients Identify and learn appropriate product details to facilitate better client interaction and troubleshooting Document and analyze call logs to spot most occurring trends to prevent future problems Maintain and update self-help documents for customers to speed up resolution time Identify red flags and escalate serious client issues to Team leader in cases of untimely resolution Ensure all product information and disclosures are given to clients before and after the call/email requests Avoids legal challenges by complying with service agreements ͏ Deliver excellent customer service through effective diagnosis and troubleshooting of client queries Provide product support and resolution to clients by performing a question diagnosis while guiding users through step-by-step solutions Assist clients with navigating around product menus and facilitate better understanding of product features Troubleshoot all client queries in a user-friendly, courteous and professional manner Maintain logs and records of all customer queries as per the standard procedures and guidelines Accurately process and record all incoming call and email using the designated tracking software Offer alternative solutions to clients (where appropriate) with the objective of retaining customers’ and clients’ business Organize ideas and effectively communicate oral messages appropriate to listeners and situations Follow up and make scheduled call backs to customers to record feedback and ensure compliance to contract /SLAs ͏ Build capability to ensure operational excellence and maintain superior customer service levels of the existing account/client Undertake product trainings to stay current with product features, changes and updates Enroll in product specific and any other trainings per client requirements/recommendations Partner with team leaders to brainstorm and identify training themes and learning issues to better serve the client Update job knowledge by participating in self learning opportunities and maintaining personal networks ͏ Deliver No Performance Parameter Measure 1 Process No. of cases resolved per day, compliance to process and quality standards, meeting process level SLAs, Pulse score, Customer feedback 2 Self- Management Productivity, efficiency, absenteeism, Training Hours, No of technical training completed Mandatory Skills: Pharmacovigilance & Drug Safety(Pharma). Experience: 1-3 Years. Reinvent your world. We are building a modern Wipro. We are an end-to-end digital transformation partner with the boldest ambitions. To realize them, we need people inspired by reinvention. Of yourself, your career, and your skills. We want to see the constant evolution of our business and our industry. It has always been in our DNA - as the world around us changes, so do we. Join a business powered by purpose and a place that empowers you to design your own reinvention. Come to Wipro. Realize your ambitions. Applications from people with disabilities are explicitly welcome.

Job Overview Assist with the overall Clinical Safety and/or PSS operations associated with products including the adverse events process which may include safety data collected from clinical trials and/or post marketing setting (i.e., unsolicited reports). Manage and process expendable adverse events to the required standard and submit them to the client and the regulatory agencies (if required) within the agreed/stated timelines. Responsible for providing this service to clients either as a support function to the client project groups or as stand- alone business. Responsible to provide all clients, both internal and external, with the appropriate quality of service in a safe and cost-effective manner. He/she will be expected to comply with the legal requirements of the Health and Safety at Work Act 1974, the COSHH regulations 1989 and the EC (European Commission) Directives 1992/3 as documented in the Company’s Health and Safety Manual. Summary Of Responsibilities Process the adverse event reports from any source as per client/sponsor agreed plans. Manage the receipt and processing of all adverse event reports reported either spontaneously from any source or from a clinical trial. This includes, but is not limited to: Data entry of safety data onto adverse event database(s) and tracking systems; Review of adverse events for completeness, accuracy, and appropriateness for expedited reporting. Write patient narratives and code adverse events accurately using MedDRA, if applicable to Determine lists against appropriate label (for Marketed products, if applicable). Identifies clinically significant information missing from initial reports and generate queries for its collection, consulting the medical staff if needed. Ensure case receives appropriate medical review. Ensure all cases that require expediting reporting to worldwide regulatory agencies or other recipients are prioritized for processing and submission within the regulatory and/or study specific applicable timelines. Submission of expedited SAE reports to clients, Regulatory Authorities, Ethics Committees, investigators, 3rd party vendors, Partners and Fortrea project personnel, if required and as agreed with client during study set-up, within study specified timelines. Perform processing of Expedited Safety Reports (ESRs), Periodic Safety Reports (PSRs) and submission, including but not limited to- o Maintenance of tracking systems. Set-up and maintenance of project files and central files for documentation. Assist with the reporting of ESRs and PSRs to clients, Regulatory Authorities, Ethics Committees, investigators, and Fortrea project personnel, as required, within study specified timelines. Support with quality review or peer review of the processed reports. Assist and/or complete the database reconciliation and the associated activities, as applicable. Maintain study/project level documentation as per the agreed requirements, as applicable. Support with training of PSS staff and mentor the team as needed. Support with input required for monthly status reports, assist in the generation and maintenance of the PSS metrics (if needed). Maintain a comprehensive understanding of Standard Operating Procedures (SOPs), Work Instructions (WI), guidance/ procedural documents and directives associated with safety management, reporting, and pharmacovigilance. Assist in the preparation for client meetings and liaise with client contacts, where appropriate. Assist in Quality issues management and support audit and inspection preparation, as needed. Ensure compliance of operations with governing regulatory requirements and applicable study/project plans and take responsibility for quality of data processed. Assist in the preparation of client meetings and liaise with clients where appropriate ¨ Any other duties as assigned by management. The above job duties are completed by the staff as applicable, depending on the role they are assigned to. Qualifications (Minimum Required) Non-degree + 1 year of Safety experience or 3 years relevant experience. Associate degree + 1 year of Safety experience or 2 years relevant experience. BS/BA + 1 year of relevant experience. MS/MA + 1 year of relevant experience. PharmD + 1 year of relevant experience. For PharmD, a one-year residency of fellowship can be considered as relevant experience. Degree preferred to be in one or more of the following disciplines: Biological Sciences, Pharmacy, Nursing, Medical Sciences, Life Sciences, or related area. Experience (Minimum Required) High degree of accuracy with attention to detail. Functions as a team player and offer peer support as needed. Good written and verbal communication skills. Ability to work independently with moderate supervision. Good keyboard skills with knowledge of MS Office and Windows application would be beneficial ¨ Mentoring skills preferred. Preferred Qualifications Include Office Environment or remote. Learn more about our EEO & Accommodations request here. Show more Show less

Summary Responsible to ensure case processing and ancillary activities in compliance with PS&PV business rules, standard operating procedures and regulatory requirements. Responsible for preparation and maintenance of manuals and other relevant/assigned documents Subject matter expert for cross-sub functional projects within PS&PV Lead implementation of new process and process amendments/changes About The Role Major Accountabilities: Monitor all case processing related activities to facilitate oversight on External Service Providers (ESP’s) quality and compliance of deliverables Evaluation and QC of Serious Adverse Event / Post Marketing Adverse Event to ensure accurate and consistent data entry and processing from source documents, with emphasis on accuracy, timeliness and quality. Perform Argus data entry as needed. Perform daily quality review (QR) for Individual Case Safety Reports (ICSR) by comparing source documents and the case information entered the safety database to ensure accurate and consistent data entry/quality. Coach/Train/Mentor other team members including ESPs, as required Lead/support the process changes according to internal and externals drivers, including development and monitoring of process related metrics Lead the preparation and maintenance of manuals and other relevant/assigned documents Participate in the creation and maintenance of training material and communications for Novartis and ESPs. Act as Subject Matter Expert / consultant to PS&PV associates, Country Organizations and other Global Line Functions on regulatory requirements and assigned business process. Develop, contribute and maintain guidance documents including providing inputs to Vigilance Agreement (VA) and other such safety management plans Support in audits/inspection as Subject Matter Expert, and develop and implement Corrective and preventative Actions (CAPA) to address safety findings Assess and analyze case processing related queries from Health Authorities and prepare and share the responses within the timelines. Support in-collaboration with other functions within PS&PV to facilitate process improvements Collaborate with Data Management team to enable reconciliation for locking of Clinical database Alert the Medical Safety Physicians of potential safety issues and assist the Medical Safety Physicians in monitoring the safety profile of products. Work with Novartis country safety departments, License partners and medical function to ensure that reports are accurately collected, evaluated and data based. Lead the testing activities for case processing related safety systems/IT applications. Lead PS&PV Operational Projects and support high complex/critical projects or database validation activities as required Minimum Requirements Graduate/Postgraduate/Doctorate degree in Life Sciences/Pharmacy/Medical Sciences or equivalent degree. 8+yrs of Industrial experience with 3 to 5 years of experience in drug safety / Development or closely related areas of responsibility Good professional verbal and nonverbal communication skills Experience in Document writing desirable Self-motivation and proactive stance to work Sense of urgency and commitment for timely completion of activities Previous Pharmacovigilance data entry experience is desirable. Strong negotiation and ability to operate effectively in a global environment and across line functions Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards Show more Show less