About the roleZevra 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 doGlobal 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
- 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.
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- MD (or equivalent medical degree) required
- 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
