(Senior-) Director Head of Medical Review (Pharmacovigilance)
BioNTech SE
August 21, 2026
Remote friendly (Cambridge, MA)
United States
Medical Affairs
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 ICSRs.
- 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 (e.g., 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.
How to Apply
- Submit CV, copy of ID, degree/professional certificates, motivation letter, and contact details via the online form.
(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 ICSRs.
- 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 (e.g., 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.
How to Apply
- Submit CV, copy of ID, degree/professional certificates, motivation letter, and contact details via the online form.