State Licensed Executive Director, Pharmacovigilance

Job Summary

Seeking a State Licensed Executive Director, Pharmacovigilance, this full-time remote position will manage the pharmacovigilance function for a clinical-stage biopharmaceutical company, overseeing safety science, operations, and regulatory interactions while building a team as the pipeline expands.

Key responsibilities

• Serve as the internal pharmacovigilance subject matter expert, providing oversight of safety data and leading safety surveillance activities
• Establish and maintain the pharmacovigilance system, ensuring compliance with global regulations and timely reporting of safety data
• Oversee outsourced pharmacovigilance activities, managing vendor relationships and ensuring quality and compliance across all programs

Required qualifications

• M.D., D.O., or equivalent degree preferred; candidates with a PharmD or Ph.D. and significant medical safety leadership experience will be considered
• Minimum 12 years of experience in pharmacovigilance or drug safety, with at least 5 years in a senior leadership role
• Oncology experience required, with a strong preference for early-phase oncology expertise
• Demonstrated knowledge of global pharmacovigilance regulations and guidelines
• Proven experience building out a pharmacovigilance function in a lean biotech environment