(Senior-) Director Head of Medical Review (Pharmacovigilance)
About The Position
As the (Senior) Director, Head of Medical Review (Pharmacovigilance), you will play a important role in ensuring the safety and compliance of BioNTech’s portfolio. Your expertise will drive the strategic development and continuous improvement of medical review processes for Individual Case Safety Reports (ICSRs). Leading a team of medical review physicians, you will foster an environment of accountability, innovation, and professional growth while ensuring alignment with global regulatory standards. This position offers a unique opportunity to contribute directly to protecting patients and supporting BioNTech’s mission. In this role, you will oversee high-impact activities ranging from medical assessment of critical safety cases to cross-functional collaboration with key departments such as Medical Safety and Global Regulatory Affairs. If you are passionate about pharmacovigilance excellence and have strong leadership capabilities, this is your chance to make a meaningful difference.
Requirements
- Medical degree or advanced life sciences degree; PhD or post-graduate training in pharmacovigilance preferred.
- 7–10 years of pharmacovigilance experience in biotech or pharmaceutical industries; oncology expertise is advantageous.
- Leadership experience as a Medical Review Lead or similar position for Senior Director consideration.
- Comprehensive knowledge of global pharmacovigilance regulations (ICH, GVP) and hands-on experience with ICSR processing.
- Proficiency in safety databases such as Veeva Vault Safety.
- Strong communication skills with the ability to convey complex concepts clearly.
- Excellent English skills.
Responsibilities
- Lead, mentor, and develop a hybrid team of in-house and vendor-based medical review physicians.
- Oversee high-quality medical assessments of ICSRs, focusing on critical cases such as SUSARs, immune-mediated events, and potential Drug-Induced Liver Injury (pDILI).
- Drive continuous improvement initiatives to optimize medical review processes for quality, compliance, and operational efficiency.
- Provide expert guidance on seriousness, causality, expectedness assessments, and regulatory reportability of ICSRs.
- Establish SOPs and work instructions for consistent medical case reviews across programs.
- Collaborate cross-functionally with teams like Global Clinical Development and Quality to ensure adherence to global pharmacovigilance standards.
- Manage vendor relationships by providing onboarding, training, quality oversight, and performance evaluation.
Benefits
- Competitive remuneration packages
- Annual bonus & equity (bonus and equity is variable and dependent on company and individual performance)
- Variety of benefits in support of our diverse employee base
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Director
