• Oversee end-to-end ICSR collection, processing, reconciliation, and reporting of post-marketing cases. • Ensure global compliance with pharmacovigilance regulations, including timely ICSR submission, high-quality case processing, and support for aggregate reporting. • Provide oversight and support of the PV vendor activities, including but not limited to the establishment and monitoring key performance indicators (KPIs) and vendor audits. • Serve as the primary point of contact for CRO pharmacovigilance teams, ensuring clear communication, accountability, and delivery of safety obligations. • Collaborate with stakeholders to ensure alignment of PV strategy, compliance, and status of the PV system. • Support development and maintenance of internal PV policies, SOPs, training programs, and the maintenance of the pharmacovigilance system. • Support safety signal detection activities and participate in safety governance committees. • Participate in regulatory inspections and PV audits to ensure quality, integrity, and compliance with pharmacovigilance and safety reporting requirements. • Lead the development and maintenance of Safety Management Plans (SMPs) and Pharmacovigilance Agreements (PVAs)/Safety Data Exchange Agreements (SDEAs). • Support and oversee deviation and Corrective and Preventive Action (CAPA) activities related to, but not limited to, expedited and periodic reporting activities, deviations related to case management processes. • Contribute to the preparation and submission of safety reports including but not limited to RMPs, DSURs, PSUR/PBRER, PADER, and PSMF. • Develop and author responses to PV-related health authority inquiries and other regulatory communications. • Other duties as assigned.