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 safety-related...
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 safety-related...
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