Director, PV & Reg Platform

Pharmacovigilance And Regulatory Platform Manager

Supports the strategic execution and governance of pharmacovigilance (PV) and regulatory platforms to ensure operational efficiency, compliance, and scalability. Drives cross-functional collaboration and system optimization to meet evolving regulatory and safety requirements.

Act as a primary interface with PV and regulatory teams for platform implementation and enhancements.

Lead day-to-day oversight of platform integration, maintenance, and user support.

Contribute to the development and execution of platform roadmaps to meet business and regulatory objectives.

Ensure alignment of platform features with global safety reporting and regulatory submission requirements.

Drive improvements in data workflows, submission processes, and inspection readiness.

Collaborate with clinical, IT, and regulatory partners to streamline and optimize platform use.

Support vendor engagement and service delivery to ensure platform performance and compliance.

Bachelor's or Master's in Life Sciences, Regulatory Affairs, Health Informatics, or related field. 10+ years of experience in pharmacovigilance, regulatory operations, or platform delivery. Deep knowledge of safety data systems and electronic regulatory submissions. Demonstrated leadership in matrixed teams and cross-functional initiatives. Familiarity with global regulations (e.g., FDA, EMA, MHRA).