Glenmark Pharmaceuticals Is Hiring an Associate Manager — Pharmacovigilance
Glenmark Pharmaceuticals, an innovation-driven global pharmaceutical company, is recruiting for an Associate Manager — Pharmacovigilance to join its Drug Safety & Risk Management division.
If you have a medical or pharmaceutical background and clinical safety management experience, this role offers direct involvement in evaluating drug safety data and authoring regulatory aggregate reports for global markets.
Job Overview
- Company: Glenmark Pharmaceuticals Ltd.
- Position: Associate Manager — Pharmacovigilance (PV)
- Department: Global Clinical Safety & Pharmacovigilance
- Location: Mumbai / Mahape (Navi Mumbai), Maharashtra, India
- Role Type: Full-time
Core Responsibilities
As an Associate Manager in PV at Glenmark, you will manage case processing oversight, aggregate safety reports, and regulatory compliance across global commercialized products and clinical trials:
- Aggregate Report Writing: Lead the authoring, review, and submission of aggregate safety documents including PBRERs, PSURs, DSURs, and PADDERs.
- Signal Detection & Risk Management: Evaluate safety data signals, participate in Risk Management Plan (RMP) development, and perform benefit-risk assessments.
- ICSR Management: Oversee end-to-end processing of Individual Case Safety Reports (ICSRs), vendor audits, and quality checks on adverse event entries in safety databases (e.g., Argus Safety).
- Audit Readiness: Coordinate internal audits and health authority inspections (US FDA, EMA, CDSCO) for the pharmacovigilance department.
Profile Requirements
| Requirement Category | Description |
|---|---|
| Education | PharmD, M.Pharm, MBBS, or Master’s in Life Sciences. |
| Experience | 5–8 years in core pharmacovigilance within a pharma company or CRO setup. |
| Technical Skills | Expertise in safety databases (Argus / ARISg), MedDRA coding, and WHO-DD dictionary. |
| Regulatory Standards | In-depth understanding of GVP (Good Pharmacovigilance Practices), ICH E2A-E2F guidelines, and US FDA/EMA safety reporting mandates. |
How to Apply
You can explore official job listings and submit your candidacy on Glenmark's official recruitment portal:
๐ Apply Directly on Glenmark Careers Portal
(Search for "Pharmacovigilance" or "Associate Manager - PV" under the Mumbai / Navi Mumbai location filter to submit your resume).