Pharmacovigilance Manager

Job OverviewWe 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 data collection forms for clinical trials - Oversee signal management activities, including literature surveillance, documentation, and tracking - Plan and review periodic aggregate safety reports including DSURs, PSURs, PBRERs, ADCOs, and line listings - Manage responses to regulatory authority queries (USFDA, Health Canada, PRAC RFIs) related to PV - Review and support labelling justification documents from a PV perspective - Contribute to risk management strategy and development of Risk Management Plans (RMPs) - Support new drug applications and other regulatory filings - Collaborate with cross-functional teams: Clinical, Regulatory Affairs, Medical Writing, Labelling, QPPV, and CROs - Act as interface between global project leads, CROs, and internal teams - Participate in Safety Governance activities - Support internal audits and regulatory inspectionsQualifications & Skills- MD/MBBS or Doctorate in Life Sciences / Pharmacy / Medicine - 7–8 years of relevant experience in Pharmacovigilance / Drug Safety - Strong exposure to clinical and post-marketing PV activities - Hands-on experience with aggregate reports, signal management, and regulatory interactions - Good understanding of global PV regulations (ICH, EMA, USFDA) - Excellent communication, stakeholder management, and documentation skills

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