Apex Laboratories is hiring for the position of Regulatory Affairs Associate at Perungudi, Chennai. Candidates with 3–5 years of experience and qualifications in M.Pharm, Pharm.D, or Life Sciences can apply. The role focuses on pharmacovigilance operations, adverse event processing, safety reporting, and regulatory documentation.
Job Details
| Particulars | Details |
|---|---|
| Company | Apex Laboratories |
| Job Title | Regulatory Affairs Associate |
| Job Category | Pharmacovigilance / Drug Safety |
| Qualification | M.Pharm / Pharm.D / Life Sciences |
| Experience | 3–5 years |
| Job Location | Perungudi, Chennai, Tamil Nadu |
| Number of Openings | 1 |
| Application Email | florencia.hr@apexlab.com |
Position
Regulatory Affairs Associate
The selected candidate will handle pharmacovigilance activities, including adverse event case processing, safety data assessment, regulatory reporting, and safety record management.
Roles and 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 using MedDRA and WHO-DD, data entry, case assessment, and follow-up activities.
- Ensure the completeness, accuracy, and quality of Individual Case Safety Reports (ICSRs).
- Perform case triage and seriousness and expectedness assessments.
- Ensure timely submission of expedited safety reports to regulatory authorities and partners.
Documentation and Record Management
- Maintain pharmacovigilance databases and safety trackers.
- Archive safety records and ensure inspection readiness.
- Prepare line listings, reconciliation reports, and safety summaries.
Eligibility and Qualifications
Candidates applying for the Regulatory Affairs Associate position at Apex Laboratories should meet the following criteria:
- Educational Qualification: M.Pharm, Pharm.D, or Life Sciences.
- Work Experience: 3–5 years.
- Job Location: Perungudi, Chennai.
Required Skills and Knowledge
The job description highlights experience or responsibilities involving:
- Pharmacovigilance operations and adverse event processing.
- Medical coding using MedDRA and WHO-DD.
- ICSR processing, assessment, and quality checks.
- Seriousness and expectedness assessment.
- Expedited safety reporting.
- Pharmacovigilance database maintenance and safety documentation.
- Reconciliation reports, line listings, and safety summaries.
How to Apply
Eligible candidates can send their updated CV to the recruitment email address below.
Email: florencia.hr@apexlab.com
Subject suggestion: Application for Regulatory Affairs Associate – Chennai
