Senior Executive – Pharmacovigilance
Location: Ahmedabad
Job Description:
Pharmazone is actively seeking a detail-driven and experienced Senior Executive – Pharmacovigilance to manage end-to-end ICSR case processing and ensure high-quality regulatory submissions. The ideal candidate will analyze safety data, handle diverse sources of adverse event reports, and collaborate with cross-functional teams to maintain compliance and data integrity.
Key Responsibilities:
Analyze and interpret safety data from clinical, non-clinical, literature, and post-marketing sources.
Perform end-to-end case processing of ICSRs, ensuring adherence to regulatory timelines.
Evaluate spontaneously reported adverse events from post-marketing surveillance studies.
Identify and manage duplicate or invalid ICSRs accurately.
Process adverse events from clinical trials, literature, spontaneous, solicited, social media, and market research sources.
Enter subject data into EDC databases and ensure its quality.
Conduct peer and quality reviews of case reports and EDC entries as required.
Raise queries for clarification of incomplete or ambiguous information.
Ensure accurate coding using MedDRA, WHO-DD, and Company Product Dictionaries.
Draft clear and comprehensive narratives for each case.
Guarantee timely and high-quality submissions in line with SLAs.
Contribute to training programs in pharmacovigilance and drug safety.
Collaborate with Regulatory Affairs to support compliant safety reporting.
Act as subject matter expert (SME) for vendor oversight in PV functions.
Train and mentor junior PV associates and assist in their professional development.
Department: Pharmacovigilance
Job Category: ICSR
Vacancy: 1
Qualification: B. Pharm, M. Pharm
Experience: 2–3 years
Job Code: PZPV012
Estimated Salary: ₹4.5 – ₹6.5 LPA (based on experience and current standards)
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