Leads pharmacovigilance operations for marketed products and clinical programs. Manages a team of PV specialists and ensures quality of safety case processing. Oversees ICSR management, aggregate report preparation, and signal detection. Ensures compliance with global PV regulations including EU, US, and CDSCO. Maintains and updates pharmacovigilance system master file (PSMF). Manages safety data exchange agreements with global partners and licensees. Leads preparation and submission of PSURs, PBRERs, and DSURs to authorities. Coordinates with regulatory affairs for labeling updates based on safety data. Represents PV function in regulatory authority inspections and audits. Manages risk minimization activities and risk management plan implementation. Provides pharmacovigilance training to medical, marketing, and field teams. Develops SOPs and quality systems for the pharmacovigilance function. Stays updated with EMA, FDA, ICH E2A-F guidelines, and PV regulations globally.