📌 Senior Drug Safety Associate | Hyderabad
📍 Location: Hyderabad, India
🕒 Experience: 2-4 years in pharmacovigilance
💼 Department: Pharmacovigilance
The Senior Drug Safety Associate will be responsible for the data entry of individual case safety reports (ICSRs) into the safety database, evaluating adverse event (AE) case information, and ensuring compliance with internal policies and procedures. The role involves medical coding, writing safety narratives, and performing reconciliation and submission activities.
✔ Data Entry: Enter individual case safety reports into the safety database.
✔ AE Case Evaluation: Review adverse event (AE) case information to determine required actions in line with internal policies.
✔ Coding & Narratives: Perform medical coding and write safety narratives for AE cases, using dictionaries like MedDRA, WHO-DD, etc.
✔ Follow-Up: Follow up with sites regarding outstanding queries and discrepancies.
✔ Reconciliation & Submission: Participate in AE reconciliation and submission activities as required.
✔ Documentation: Ensure adherence to good documentation practices and internal AE workflow procedures.
✔ Other Tasks: Perform other drug safety-related activities as assigned by the department.
🎓 Education: Graduate/Post Graduate/Doctorate degree in Life Sciences, Pharmacy, Medical Sciences, or an equivalent degree.
💼 Experience:
This position is on-premise.
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