About the Role
About the Role
We are seeking a senior PV leader to oversee pharmacovigilance operations, ensure regulatory compliance, and drive operational excellence across global safety programs.
Key Responsibilities
Lead and oversee end-to-end PV Operations, including ICSR management and compliance.
Provide strategic oversight of SDEA and safety risk management activities.
Own SDB optimization strategy, system governance, and quality frameworks.
Develop, review, and approve global PV SOPs and compliance processes.
Lead inspection readiness, audits, and health authority interactions.
Mentor and manage PV teams; ensure performance, quality, and delivery excellence.
Collaborate with sponsors, CRO partners, and cross-functional stakeholders.
Requirements
10+ years of experience in Pharmacovigilance / Safety Operations.
Proven leadership experience in PV compliance, audits, and inspections.
Deep expertise in ICSRs, SDEA, SOPs, and safety database governance.
Strong regulatory knowledge (ICH, GVP Modules, FDA, EMA).
Excellent stakeholder management and leadership skills.