Senior Manager - Pharmacovigilance @ Bharat Serums Vaccines

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.

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Rs 0 - 50K PM Rs 50K - 1 LPA Rs 1.0 - 1.5 LPA Rs 1.5 - 2.0 LPA Rs 2.0 - 2.5 LPA Rs 2.5 - 3.0 LPA Rs 3.0 - 3.5 LPA Rs 3.5 - 4.0 LPA Rs 4.0 - 4.5 LPA Rs 4.5 - 5.0 LPA Rs 5 - 6 LPA Rs 6 - 7 LPA Rs 7 - 8 LPA Rs 8 - 9 LPA Rs 9 - 10 LPA Rs 10 - 12 LPA Rs 12 - 14 LPA Rs 14 - 16 LPA Rs 16 - 18 LPA Rs 18 - 20 LPA Rs 20 - 22 LPA Rs 22 - 24 LPA Rs 24 - 26 LPA Rs 26 - 28 LPA Rs 28 - 30 LPA Rs 30 - 32 LPA Rs 32 - 34 LPA Rs 34 - 36 LPA Rs 36 - 38 LPA Rs 38 - 40 LPA Rs 40 - 42 LPA Rs 42 - 44 LPA Rs 44 - 46 LPA Rs 46 - 48 LPA Rs 48 - 50 LPA Rs 50 - 75 LPA Rs 75 Lakh - 1C PA Rs 1 Crore+ PA

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Keyskills:   Pharmacovigilance