Medical Director, Pharmacovigilance; PV

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.

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.

• 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.

• 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
  • Risk Management Plans (RMPs)
• 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.

• 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.

• 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…