Job Description
Job Overview
We are seeking an experienced Pharmacovigilance professional with strong expertise across drug development, registration, and post-approval phases for New Chemical Entities (NCEs). The role will be responsible for end-to-end safety activities, regulatory compliance, signal management, and benefit–risk assessment across global programs.
Key Responsibilities
- Lead and manage PV safety activities for assigned New Chemical Entities (NCEs)
- Ensure timely completion of safety deliverables in compliance with global regulations and internal SOPs
- Define safety data acquisition strategy, methodology, and analytical approach
- Review and provide input on study protocols, safety management plans, and safety reporting requirements
- Review adverse events (AEs) and serious adverse events (SAEs) from clinical studies
- Review safety data (tables, figures, listings), Clinical Study Reports (CSRs), and Investigator Brochures (IBs)
- Support development of saf...
We are seeking an experienced Pharmacovigilance professional with strong expertise across drug development, registration, and post-approval phases for New Chemical Entities (NCEs). The role will be responsible for end-to-end safety activities, regulatory compliance, signal management, and benefit–risk assessment across global programs.
Key Responsibilities
- Lead and manage PV safety activities for assigned New Chemical Entities (NCEs)
- Ensure timely completion of safety deliverables in compliance with global regulations and internal SOPs
- Define safety data acquisition strategy, methodology, and analytical approach
- Review and provide input on study protocols, safety management plans, and safety reporting requirements
- Review adverse events (AEs) and serious adverse events (SAEs) from clinical studies
- Review safety data (tables, figures, listings), Clinical Study Reports (CSRs), and Investigator Brochures (IBs)
- Support development of saf...
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