Medical Director, Pharmacovigilance (PV)
Zevra Therapeutics, Inc. · Boston, MA
The role
Zevra Therapeutics seeks a Senior Medical Director of Pharmacovigilance to lead global safety oversight for clinical development programs and marketed products. The role involves serving as Global Safety Lead, partnering with the QPPV, ensuring regulatory compliance, and providing strategic safety leadership. The position is based in Boston, Massachusetts.
- Location
- Boston, MA
- Level
- Senior
- Experience
- 10+ yrs
- Education
- Masters
What we know that the posting doesn’t say
- Seen 2 days agostill listed on the employer’s careers page
About Zevra Therapeutics, Inc.
Zevra Therapeutics is a rare disease therapeutics company focused on developing life-changing treatments for patients with significant unmet needs, involving key stakeholders in development strategies.
What you would do
- Lead global safety oversight for assigned products across development and post-marketing
- Assess benefit-risk profiles and ensure timely safety signal identification and communication
- Oversee signal detection, validation, and risk assessment activities
- Provide medical leadership for DSURs, PBRERs, and Risk Management Plans
- Ensure compliance with FDA, EMA, and ICH pharmacovigilance regulations
- Represent pharmacovigilance in regulatory interactions and health authority inspections
Must have
- MD or equivalent medical degree required
- Minimum 10+ years pharmacovigilance experience in biopharmaceutical industry
- Demonstrated experience as Global Safety Lead or comparable senior role
- Strong experience partnering with QPPV and supporting EU requirements
- Deep knowledge of FDA, EMA, and ICH pharmacovigilance regulations
- Proven ability to lead benefit-risk assessments and signal management
- Experience supporting regulatory inspections and health authority interactions
- Strong leadership, communication, and cross-functional influencing skills
- Ability to operate strategically with attention to executional excellence
Nice to have
- Experience in rare disease and/or small biotech settings
Experience and education
- 10+ years of relevant experience
- Masters degree or equivalent experience
Key skills
- pharmacovigilance
- signal detection
- benefit-risk assessment
- dsur
- pbrer
- pader
- rmp
- psmf
- fda regulations
- ema regulations
- ich guidelines
- gvp
- regulatory inspections
- clinical development
- medical affairs
- regulatory affairs
- quality
- vendor management
- cro management
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…
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