Regulatory Affairs Associate

apex laboratories; Chennai; On-site; INR 500,000 - 800,000; Full time

Job summary

Apex Laboratories in Chennai (Perungudi) invites a Pharmacovigilance professional to join our operations team. You will receive, review, process, and document AE/SAE/ADR reports, perform case intake and medical coding, ensure ICSRs quality, triage cases, and timely submission to regulators and partners.

Ideal candidates have 3–5 years of PV experience and hold M.Pharm, Pharm D, or Life Sciences degrees. This on-site role offers a challenging environment with growth opportunities in a supportive,

Qualifications

• Experience in Pharmacovigilance operations and high attention to detail.

Responsibilities

• 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.
• Maintain PV databases and safety trackers; archive safety records; prepare line listings, reconciliation reports, and safety summaries.

Education

M.Pharm

Pharm D

Life Sciences

Job description

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