Apotex is hiring for the position of Lead Exec, GBS-GMA-GPV PSRM-GBS-PSRM G in Mumbai, Maharashtra. The role focuses on preparing and reviewing periodic safety update reports, evaluating safety data, supporting pharmacovigilance activities, and contributing to global new product development and Product Life Cycle Management activities.
Job Details
| Details | Information |
|---|---|
| Company | Apotex |
| Job Title | Lead Exec, GBS-GMA-GPV PSRM-GBS-PSRM G |
| Location | Mumbai, Maharashtra, India – 400079 |
| Date | September 30, 2026 |
| Experience | 3–5 years of pharmaceutical experience in core Pharmacovigilance |
| Preferred Experience | 1–2 years in periodic reviews of aggregate safety data |
Position
Lead Exec, GBS-GMA-GPV PSRM-GBS-PSRM G
The position is responsible for PSUR/PBRER/PADER preparation and peer review, safety data analysis, regulatory compliance, literature monitoring, and support for new product development and Product Life Cycle Management activities.
Responsibilities
- Prepare and conduct peer reviews of PSURs, PBRERs and PADERs for regulatory submission.
- Monitor safety issues related to Apotex products through ongoing monitoring and literature review.
- Analyze and interpret safety data using scientific skills.
- Prepare responses to more complex safety information queries from Regulatory Affairs, Quality Assurance and NPD project teams.
- Promptly resolve causality assessment queries and reporting issues by liaising with reporting sites.
- Develop and maintain SOPs.
- Develop and maintain training documents and track compliance of internal and external global partners involved in drug safety reporting.
- Maintain user-level knowledge of Oracle ARGUS and MedDRA terminology.
- Contribute to process improvement strategy discussions.
- Support teamwork and timely delivery of quality drug safety data.
- Develop working relationships with external partners and international Apotex affiliates.
- Contribute to the interpretation of Pharmacovigilance regulations and application of regulatory guidelines and policies.
- Remain current on new Pharmacovigilance regulations and international guidelines.
- Participate in global new product development projects and support Product Life Cycle Management activities.
- Perform work in accordance with ICH guidelines, regulatory compliance requirements and safety requirements.
Eligibility & Qualifications
Candidates should have one of the following educational backgrounds:
- Physicians
- Pharm.D
- M.Pharm
- Nursing
- Related Health Science discipline
Experience
- 3–5 years of core Pharmacovigilance experience in the pharmaceutical industry
- 1–2 years of experience in periodic reviews of aggregate safety data is preferred.
Required Skills
- Excellent analytical and problem-solving skills.
- Excellent oral and written communication skills in English.
- Knowledge of MedDRA.
- Knowledge of Oracle ARGUS.
- Knowledge of online literature searching.
- Strong organizational and interpersonal skills.
- Ability to work in a dynamic team environment.
- Strong knowledge of relevant local and international regulations.
- Strong knowledge of ICH guidelines for safety data management in clinical trials and post-approval settings.
- Advanced knowledge of Microsoft Excel, PowerPoint and Word.
Application Details
Company: Apotex
Position: Lead Exec, GBS-GMA-GPV PSRM-GBS-PSRM G
Location: Mumbai, Maharashtra, India – 400079
Experience: 3–5 years of core Pharmacovigilance pharmaceutical experience
Preferred Experience: 1–2 years in periodic reviews of aggregate safety data
Education: Physicians, Pharm.D, M.Pharm, Nursing or related Health Science discipline
