Regulatory Affairs Associate

Role & responsibilities

Pharmacovigilance Operations

• Receive review, process, and document adverse event (AE), serious 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 removed]