Pharmacovigilance Manager

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, lis...