• Oversee all safety reporting activities managed by CROs and consultants, including expedited reporting (SAEs, SUSARs) and periodic aggregate safety reports (DSURs, PSURs/PBRERs). • Serve as the primary point of contact for CRO pharmacovigilance teams, ensuring clear communication, accountability, and delivery of safety obligations. • Develop, negotiate, and manage PV sections of contracts, safety management plans, and operational agreements with CROs and consultants. • Monitor CRO performance through KPIs, audits, and oversight activities, ensuring timely and accurate reporting to regulatory authorities, ethics committees, and investigators. • Collaborate with internal stakeholders (Clinical Development, Regulatory Affairs, Quality, Legal) to ensure alignment on PV strategy and compliance. • Provide oversight for case processing, medical review, and data reconciliation activities performed by CROs and consultants. • Ensure compliance with global regulations (FDA, EMA, MHRA, ICH, GVP, etc.) and maintain inspection readiness. • Support development and maintenance of internal PV policies, SOPs, and training programs. • Participate in safety signal detection activities and safety governance committees, as needed. • Oversee maintenance and compliance of an externally hosted electronic safety database for tracking, storing, and reporting of serious adverse events. • Participate in regulatory inspections and PV audits to ensure quality, integrity, and compliance with pharmacovigilance and safety reporting requirements per SOPs and global regulations.