Career Opportunities: SCIENTIST (20496)
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Career Opportunities: SCIENTIST (20496)
Requisition ID
20496
- Posted
10/27/2025
-
BIOCON PHARMA LIMITED
-
MEDICAL AFFAIRS & NRA
-
India
Job Description Print Preview
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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
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