(Senior-) Director Head of Medical Review (Pharmacovigilance)

Mainz, Germany; London, United Kingdom; Munich, Germany | full time | Job ID: 11466

About the Role

As the (Senior) Director, Head of Medical Review (Pharmacovigilance), you will play an 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.

Responsibilities

• Lead, mentor, and develop a hybrid team of in‑house and vendor‑based medical review physicians.
• Oversee high‑quality medical assessments of ICSR cases, 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 ICSR cases.
• 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.

Qualifications

• 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.

Benefits

BioNTech is committed to the wellbeing of our team members and offers a variety of benefits in support of our diverse employee base. We offer competitive remuneration packages which are determined by the specific role, location of employment and also the selected candidate’s qualifications and experience. Note: The availability, eligibility and design of the listed benefits may vary depending on the location. The final requirements for the individual use of our benefits are based on the company’s internal policies and applicable law.