Senior Safety Scientist

Mainz, Germany; London, United Kingdom; Munich, Germany | full time | Job ID: 9852

Senior Safety Scientist

As a Senior Safety Scientist , you will provide scientific and strategic expertise to our clinical development programmes at a compound level. Core responsibilities include safety data review, periodic report contributions, and oversight of the safety surveillance process.

Your main responsibilities are:

• Lead cumulative and ongoing safety data reviews across programs, including early‑phase clinical trials, to assess overall safety profiles, identify emerging risks, trends, or signals, and characterize evolving safety profiles.
• Drive signal detection and management activities for assigned programs, including defining search criteria (SMQs, CMQs, KURs), reviewing ICsRs, evaluating aggregate data for emerging trends, and maintaining STAR documentation.
• Lead the preparation and presentation of safety signal assessments and safety surveillance summaries for Safety Surveillance Teams (SSTs), Safety Management Teams (SMTs) and joint partner meetings (JSMT/JSC).
• Recommend and monitor risk‑mitigation actions and ensure appropriate documentation of signal evaluation outcomes.
• Serve as main clinical safety contributor for Development Safety Update Reports (DSURs), Periodic Safety Update Reports (PSURs/PBRERs), and safety sections of regulatory submissions (e.g. BLA, MAA) including Health Authority (HA) queries and briefing documents.
• Partner with Safety Physicians and cross‑functional teams to interpret safety data, shape clinical strategies, and ensure consistent safety oversight.
• Provide safety input to clinical and regulatory documents, including clinical trial protocols, Investigator’s Brochures (IBs), Clinical Study Reports (CSRs), and Informed Consent Forms (ICFs).
• Support audit and inspection readiness by ensuring documentation and traceability of key safety surveillance activities.
• Build subject matter expertise in focus areas such as data analytics, signal detection, BRA, or literature review.

What you have to offer:

• Advanced degree in Life Sciences, Pharmacy, Public Health or a related field (PhD preferred)
• At least 5 years of experience in drug safety in a pharmaceutical, biotech, or CRO environment
• Strong knowledge of applicable regulatory, GCP, and GVP requirements in key geographies
• Demonstrable experience in signal detection and management, safety surveillance and the preparation of safety‑aggregate reports.
• Strong analytical and critical thinking skills with the ability to review complex safety data and present findings in a clear and structured manner
• Excellent verbal and written communication skills with the ability to partner with multiple stakeholders across functions and levels
• Fluent in written and spoken English

What we do with the BioNTainers:

We want to improve healthcare by making our innovations accessible worldwide. Therefore, we developed the first modular mRNA‑manufacturing facilities based on a container solution called “BioNTainers”. Help us build a regional manufacturing network in Africa & Australia: With the region and for the region. As a part of the local team, driving the establishment of the regional end‑to‑end mRNA manufacturing solutions.

Benefits for you:

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.
Click here to find out more about what we do, the careers we offer and also the benefits we provide. 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.
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.
We are looking forward receiving your application.

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