Medical Director, Pharmacovigilance (PV)
Medical Director, Pharmacovigilance (PV) About Zevra Therapeutics, Inc. We are a rare disease therapeutics company leading with science to make life‑changing therapeutics available to patients with significant unmet needs. We involve key thought leaders, physicians, patients, care partners, and advocacy groups in all of our clinical and regulatory development strategies. With a keen understanding that drug development often requires creative solutions, we have the insight and expertise to forge new pathways to success that others have missed. By following the data without bias, our transparent narratives and common‑sense perspective have successfully overcome complex development challenges to make much‑needed therapies available to patients. Nimble and dauntless, we push boundaries beyond what is thought to be possible and advance new therapies that have the potential to bring meaningful improvement to patients’ lives. About the role Zevra Therapeutics is a rare disease company committed to improving the lives of patients with serious, underserved conditions. 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. This role serves as a senior medical leader within the organization, responsible for advancing a proactive, science‑driven approach to pharmacovigilance, ensuring patient safety, and maintaining compliance with global regulatory requirements. 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. The Medical Director will serve as a key partner to the Qualified Person for Pharmacovigilance (QPPV), ensuring alignment across global and EU pharmacovigilance obligations, and will provide expert guidance to executive leadership on safety‑related risks and regulatory implications. This position will be based in Boston, Massachusetts. What you’ll do Global Safety Leadership Serve as Global Safety Lead (GSL) for assigned products across clinical development and post‑marketing phases. Lead the ongoing assessment of benefit‑risk profiles, ensuring timely identification, evaluation, and communication of safety signals. Oversee and contribute to signal detection, validation, and risk assessment activities, ensuring scientific rigor and regulatory alignment. Regulatory & Compliance Oversight Provide medical leadership in the preparation, review, and approval of key safety deliverables, including: Development Safety Update Reports (DSURs) Periodic Benefit‑Risk Evaluation Reports (PBRERs) / PADERs Ensure adherence to global pharmacovigilance regulations, including FDA, EMA, and ICH guidelines, and maintain a state of inspection readiness. Represent Pharmacovigilance in regulatory interactions, audits, and health authority inspections. QPPV Partnership & EU Compliance Act as the senior medical partner to the QPPV, ensuring strong alignment on safety strategy and regulatory obligations. Ensure timely escalation of emerging safety signals and critical risks to the QPPV and senior leadership. Support maintenance of the Pharmacovigilance System Master File (PSMF) and ensure compliance with EU Good Pharmacovigilance Practice (GVP) requirements. Ensure appropriate QPPV visibility into safety governance, decision‑making processes, and risk mitigation strategies. Cross‑Functional Leadership & Governance Lead and participate in cross‑functional safety governance forums, ensuring appropriate escalation and management of safety issues. Partner closely with Clinical Development, Regulatory Affairs, Medical Affairs, Quality, and Commercial teams to ensure alignment on safety strategy and execution. Provide expert medical input into clinical protocols, investigator brochures, labeling, and risk mitigation strategies. Operational Oversight Oversee pharmacovigilance operations, including vendors, CROs, and strategic partners, ensuring high‑quality and compliant execution of PV activities. Ensure effective implementation of PV systems, processes, and quality standards across the organization. Strategic Leadership Advise executive leadership on benefit‑risk strategy, safety‑related regulatory risks, and implications for development and commercialization decisions. Contribute to enterprise‑level strategy by integrating safety considerations across the product lifecycle. Stay current with emerging trends, regulatory changes, and best practices in pharmacovigilance and patient safety. Qualifications Minimum of 10 years of pharmacovigilance experience within the biopharmaceutical industry Demonstrated experience as a Global Safety Lead or in a comparable senior safety leadership role Strong experience working in partnership with a QPPV and supporting EU pharmacovigilance requirements Deep knowledge of global pharmacovigilance regulations, including FDA, EMA, and ICH guidelines Proven ability to lead benefit‑risk assessments, signal management, and regulatory safety deliverables Experience supporting regulatory inspections and health authority interactions Strong leadership, communication, and cross‑functional influencing skills Ability to operate strategically while maintaining attention to executional excellence in a fast‑paced, growth‑stage environment Experience in rare disease and/or small biotech settings strongly preferred Equal Employment Opportunity Statement Zevra is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. J-18808-Ljbffr
