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

Senior- Director Head Of Medical Review (Pharmacovigilance)

Cambridge, US; Gaithersburg, US; London, United Kingdom; Mainz, Germany; Munich, Germany | Full Time

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. 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.

Your Contribution:

• 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.

A Good Match:

• Medical degree or advanced life sciences degree; PhD or post-graduate training in pharmacovigilance preferred.
• 710 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.

Your Benefits And Remuneration:

If the position is filled in the US, the expected pay range for Director is $168,100/year to $268,700/year and Senior Director is $198,900/year to $318,300/year + benefits, annual bonus & equity (bonus and equity is variable and dependent on company and individual performance). Compensation for the role will depend on several factors, including responsibilities of the job, education, experience, knowledge, skills, and abilities. Compensation at other locations may vary significantly. 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 is 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.

How To Apply: Apply now by sending us your application documents including Curriculum Vitae, copy of ID, copies of degree certificates and professional certificates, motivation letter as well as your contact details via our online form. Please note: Only applications sent via our online form shall be considered. By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider 'HireRight'. You will be informed accordingly by your BioNTech-Recruiter.

Inspired? Become part of #TeamBioNTech. BioNTech, the story At BioNTech, we are more than just a biotechnology company we are a community of innovators, scientists, and leaders dedicated to revolutionizing medicine by translating cutting-edge science into survival. Your contributions here have the potential to improve the health of people worldwide, especially by addressing diseases with high medical needs like cancer and various infectious diseases. Experience a dynamic workplace that embraces diversity in all its forms. We foster innovation, encourage creativity, and develop business strategies driven by our shared passion for advancing medicine. Working at BioNTech means striving to achieve medical breakthroughs while growing your career in a meaningful way. Apply today and become part of a mission that has the potential to change lives around the world. BioNTech does not tolerate discrimination, favoritism or harassment based on gender, political views, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other physical or personal characteristics. BioNTech is committed to creating a diverse and inclusive work environment. We are proud to be an equal opportunity employer. The main thing is that you suit us, and we suit you! BioNTech - As unique as you