Senior Medical Director, Pharmacovigilance (PV)

Zevra Therapeutics•Boston, MA

2d•Onsite

About The Position

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 Senior 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.

Requirements

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

Nice To Haves

Experience in rare disease and/or small biotech settings strongly preferred

Responsibilities

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 strategy and execution.
Provide expert medical input into clinical protocols, investigator brochures, labeling, and risk mitigation strategies.
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.
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.