Executive Director - Pharmacovigilance - CEDENT

The Executive Director of Pharmacovigilance leads pharmacovigilance and risk management activities, ensuring compliance with global safety regulations and aligning with corporate clinical and commercial goals. Reporting to the VP of Pharmacovigilance, this role oversees pharmacovigilance operations for investigational and marketed products, manages vendor performance, and provides strategic input to regulatory submissions and risk mitigation.
 

• Develop and implement global pharmacovigilance strategies to ensure regulatory compliance and alignment with corporate objectives.

• Lead pharmacovigilance operations for clinical and marketed products, with oversight of vendor activities for timely report processing and submission.

• Oversee signal detection, risk management, and risk mitigation to safeguard patient safety across products.

• Provide strategic input for regulatory submissions (IND, NDA, labeling) and contribute to safety documentation for clinical trials.

• Support clinical development by providing safety input on protocols, informed consents, and data monitoring committee activities.

• Serve as the pharmacovigilance expert for internal process development, vendor training, and regulatory authority interactions.

• Lead pharmacovigilance governance and communications regarding product risk-benefit profiles with internal and external stakeholders.

• Manage pharmacovigilance activities during regulatory inspections and represent the function in senior leadership committees.
   

• Bachelor’s degree in a scientific field required; MD or advanced degree preferred.

• 12-15 years of experience in life sciences or pharmaceuticals, with at least 8 years in global pharmacovigilance and drug safety.

• 6-8 years of leadership experience managing teams and external partners.

• Expertise in global safety regulations (FDA, EU GVP, ICH), clinical safety assessments, and regulatory submissions.

• Proven problem-solving, organizational, and decision-making skills, with the ability to navigate a dynamic, matrixed environment.

• Effective communicator with experience coordinating across levels, including senior management.