Department Details

Medical Affairs Clinical Research & NRA

Role Summary

Pharmacovigilance role (Scientist / Senior Scientist role)

Key Responsibilities

- Handling Pharmacovigilance activities.
- Operational oversight of Individual Case Safety Report (ICSR) case processing and Medical Information Call Center (MICC) activities.
- Provide oversight and ensure timely delivery of monthly updates related to MICC call volumes and ICSR processing activities
- Oversight of call logs for quality & resolve queries raised from the calls.
- Regular reconciliation reviews of MICC call records and ICSRs processed by external PV vendors
- Oversight and review literature search processes to identify relevant safety information for ICSRs, Signal, PSUR etc
- Oversight of PV Safety Database and Case Processing Teams




- Provide and verify regulatory submission Compliance for ICSRs and PSURs.
- Oversight of Reconciliation activity for ICSR's, MICC and SDEA.
- Maintenance of BPL Product Dictionary and Regulatory submission activity.
- Handling of Pharmacovigilance (PV) safety Database administration & Query resolution.
- Drafting and Review of Safety Data Exchange Agreements (SDEAs) between business Partners and BPL Cross-Functional Team (CFT)
- Stakeholder collaboration across cross-functional stakeholders including RA, QA, Legal, Finance, Packaging, Commercial, PQC and BBL

Educational Qualifications

Required Education Qualification: B.Sc
Required Experience: 1 - 6 years

📌 SCIENTIST (India)
🏢 Biocon
📍 India