Director

• Serve as the PV lead for assigned programs, accountable for end-to-end safety deliverables including signal detection, aggregate reporting, and risk management planning.
• Represent PV on program-level governance committees and cross-functional teams, ensuring clear role delineation between PV and Clinical Development.
• Lead the preparation and PV input into protocols, Investigator Brochures, ICFs, SAPs, CSRs, regulatory submissions, and labeling documents for assigned programs.
• Develop and maintain program-level PV strategies aligned with global regulatory requirements and company objectives.
• Lead PV contributions to regulatory authority interactions and inspection readiness activities for assigned programs.
• Partner with CROs and vendors to ensure timely and compliant PV deliverables; monitor performance and escalate issues as needed.
• Contribute to departmental process improvement and knowledge-sharing initiatives.
• Mentor junior staff or consultants supporting PV deliverables.

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