(Senior-) Director Head of Medical Review (Pharmacovigilance)
Scorpion Therapeutics · Cambridge, MA
FULL-TIME
Posted Sep 25, 2026
168K–269K a year
Job Description
About the Role (Senior) Director, Head of Medical Review (Pharmacovigilance) Responsibilities
• Lead, mentor, and develop a hybrid team of in-house and vendor-based medical review physicians.
• Oversee high-quality medical assessments of Individual Case Safety Reports (ICSRs), including critical cases (SUSARs, immune-mediated events, potential Drug-Induced Liver Injury/pDILI).
• Drive continuous improvement to optimize medical review processes for quality, compliance, and operational efficiency.
• Provide expert guidance on seriousness, causality, expectedness, and regulatory reportability of IC.
• Establish SOPs and work instructions for consistent medical case reviews across programs.
• Collaborate cross-functionally with Global Clinical Development and Quality to ensure adherence to global pharmacovigilance standards.
• Manage vendor relationships (onboarding, training, quality oversight, and performance evaluation). Qualifications/Skills
• Medical degree or advanced life sciences degree; PhD or post-graduate training in pharmacovigilance preferred.
• 7-10 years of pharmacovigilance experience in biotech/pharmaceutical industries; oncology expertise advantageous.
• Leadership experience as a Medical Review Lead (or similar) for Senior Director consideration.
• Comprehensive knowledge of global pharmacovigilance regulations (ICH, GVP) and hands-on ICSR processing experience.
• Proficiency with safety databases (eg, Veeva Vault Safety).
• Strong communication skills; ability to convey complex concepts clearly.
• Excellent English. Benefits (if US)
Expected pay range: Director $168,100-$268,700/year; Senior Director $198,900-$318,300/year + benefits, annual bonus & equity.
• Lead, mentor, and develop a hybrid team of in-house and vendor-based medical review physicians.
• Oversee high-quality medical assessments of Individual Case Safety Reports (ICSRs), including critical cases (SUSARs, immune-mediated events, potential Drug-Induced Liver Injury/pDILI).
• Drive continuous improvement to optimize medical review processes for quality, compliance, and operational efficiency.
• Provide expert guidance on seriousness, causality, expectedness, and regulatory reportability of IC.
• Establish SOPs and work instructions for consistent medical case reviews across programs.
• Collaborate cross-functionally with Global Clinical Development and Quality to ensure adherence to global pharmacovigilance standards.
• Manage vendor relationships (onboarding, training, quality oversight, and performance evaluation). Qualifications/Skills
• Medical degree or advanced life sciences degree; PhD or post-graduate training in pharmacovigilance preferred.
• 7-10 years of pharmacovigilance experience in biotech/pharmaceutical industries; oncology expertise advantageous.
• Leadership experience as a Medical Review Lead (or similar) for Senior Director consideration.
• Comprehensive knowledge of global pharmacovigilance regulations (ICH, GVP) and hands-on ICSR processing experience.
• Proficiency with safety databases (eg, Veeva Vault Safety).
• Strong communication skills; ability to convey complex concepts clearly.
• Excellent English. Benefits (if US)
Expected pay range: Director $168,100-$268,700/year; Senior Director $198,900-$318,300/year + benefits, annual bonus & equity.
Additional Details
- City
- Cambridge
- State
- Massachusetts
- Country
- US
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