Zevra Therapeutics
Medical Director, Pharmacovigilance (PV)
Boston, MA · Director
Sponsorship not specifiedDetected 20 days ago
Product ManagementHRFDA RegulatoryPharmacovigilanceLeadershipCommunicationRegulatory Affairs
About the role
- Zevra Therapeutics is a rare disease company committed to improving the lives of patients with serious, underserved conditions.
- The individual will play a critical role in evaluating and communicating benefit-risk profiles, supporting regulatory interactions, and shaping safety strategy across the product lifecycle.
- This position will be based in Boston, Massachusetts.
Responsibilities
- Support maintenance of the Pharmacovigilance System Master File (PSMF) and ensure compliance with EU Good Pharmacovigilance Practice (GVP) requirements.
- We involve key thought leaders, physicians, patients, care partners, and advocacy groups in all of our clinical and regulatory development strategies.
- W hat you'll do Global Safety Leadership Serve as Global Safety Lead (GSL) for assigned products across clinical development and post-marketing phases.
Requirements
- All candidate submissions must be coordinated through our Human Resources team and require a prior written agreement.
Benefits
- We are seeking a highly experienced and strategic Senior Medical Director, Pharmacovigilance to lead global safety oversight across our clinical development programs and marketed products.
- Lead the ongoing assessment of benefit-risk profiles, ensuring timely identification, evaluation, and communication of safety signals.
Company info
- We are a rare disease therapeutics company leading with science to make life-changing therapeutics available to patients with significant unmet needs.
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