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SCIENTIST

Biocon · Remote

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Employer requisition: 20496

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Collected role description

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