Senior Director Drug Safety

We are partnering with an industry-leading biopharmaceutical company to identify an accomplished Director or Senior Director of Pharmacovigilance. This is a strategic role for a talented Medical Director (MD) to take the helm of safety oversight for cutting-edge Phase 3 clinical trials, ensuring exceptional patient safety and clinical success.About the RoleIn this critical leadership position, you'll oversee and manage pharmacovigilance operations, collaborating closely with the Clinical Development and external partners. The scope includes directing outsourced case management and medical reviews while providing expert medical monitoring for pivotal clinical programs.This is an outstanding opportunity for a seasoned professional to make a significant impact in a forward-thinking, patient-centric organization.Key Responsibilities:Safety Management Leadership:Direct all pharmacovigilance operations, focusing on outsourced case processing and medical reviews.Ensure robust compliance with global safety regulations and reporting standards.Medical Oversight of Clinical Trials:Provide leadership in medical monitoring across ongoing and future Phase 3 trials, working in partnership with the CRO to deliver operational excellence.Analyze and interpret safety data, contributing to protocol optimization and risk mitigation strategies.Collaboration and Strategy:Act as a critical interface between cross-functional internal teams and external stakeholders, driving efficient execution of safety strategies.Contribute to the development of a proactive safety culture within the clinical organization.Your ProfileQualified MD with 8+ years of pharmacovigilance experience in the biopharma or biotech sector.Demonstrated expertise in managing outsourced PV operations, including case processing and review.Proven capability in clinical trial medical monitoring, particularly in late-stage clinical studies.Thorough understanding of global pharmacovigilance regulations and guidelines (e.g., GCP, GVP).Adept at strategic thinking, problem-solving, and collaborative leadership.

Created: 2024-11-11