Role & responsibilities
Pharmacovigilance Operations
- Receive review, process, and document adverse event (AE), responsible adverse event (SAE), adverse drug reaction (ADR), and product quality complaint reports.
- Perform case intake, medical coding (MedDRA/WHO-DD), data entry, case assessment, and follow-up activities.
- Ensure completeness, accuracy, and quality of Individual Case Safety Reports (ICSRs).
- Perform case triage and seriousness/expectedness assessment.
- Ensure timely submission of expedited safety reports to regulatory authorities, and partners.
Documentation & Record Management
- Maintain PV databases and safety trackers.
- Archive safety records and ensure inspection readiness.
- Prepare line listings, reconciliation reports, and safety summaries.
Preferred candidate profile
Experience - 3 - 5 years
Qualification - M.Pharm / Pharm D / Life Sciences
Work Location - Perungudi, Chennai
Interested candidates send your CVs to
[email protected]
📌 Regulatory Affairs Associate (Chennai)
🏢 Apex Laboratories
📍 Chennai