Senior Manager - Pharmacovigilance
- Bharat Serums Vaccines
- 10 - 15 years
- Mumbai
- 3 months ago
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Job Description
Key Responsibilities:
1. Serve as a Responsible person for Pharmacovigilance officer in-charge (PvOI) for organization.
2. Developing Pharmacovigilance (PV) training modules and organizing PV training for PV team members and other relevant staff.
3. Collection of AE reports and other pharmacovigilance relevant data.
4. Management of PV database.
5. Ensuring the necessary quality, including the correctness and completeness of pharmacovigilance data.
6. ICSR processing specifically reviewing MedDRA coding of data, assessment in terms of diagnosis and/or seriousness, Causality and seriousness assessment. Monitoring timely submission to regulatory authority.
7. Literature search to identify relevant adverse event cases.
8. Preparation/review of contractual arrangements with other persons/organizations with regards to pharmacovigilance obligations
9. SDEA initiation with new parties and renewal.
10. Assessing safety data and proposing risk minimization measures.
11. Preparation/update/review of SOPs, PSURs, RMPs, contractual agreements etc.
12. Review of compliance data regarding quality, completeness and timeliness of expedited reporting and submission of periodic update reports, audit reports and training of personnel in relation to pharmacovigilance.
Job Classification
Industry: Pharmaceutical & Life SciencesFunctional Area / Department: Research & DevelopmentRole Category: Pharmaceutical & BiotechnologyRole: Pharmaceutical & Biotechnology - OtherEmployement Type: Full timeContact Details:
Company: Bharat Serums VaccinesLocation(s): Mumbai
Keyskills: Pharmacovigilance
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