
Pharmacovigilance Executive
Klinscience Healthcare Pune
About the Role
A pharmacovigilance role involves monitoring, detecting, assessing, and preventing adverse drug reactions (ADRs) and safety issues across a medication's lifecycle to protect patient health and ensure compliance with global health authorities.
Key Responsibilities
- Case Processing: Collect, triage, and process Individual Case Safety Reports (ICSRs) for adverse events.
- Medical Coding: Code adverse events and medical history using standardized terminology like MedDRA and WHO dictionaries.
- Narrative Writing: Write clear patient event timelines and clinical summaries from drug initiation to reaction onset.
- Causality & Compliance Assessment: Evaluate the causal relationship between a drug and an adverse event, ensuring strict adherence to 7-to-15-day reporting timelines for serious cases.