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Clinical Safety Specialist (m/w/d)

BioNTech AG
55131 Mainz
Vollzeit
30.06.2025
Vollzeit

Stellenbeschreibung

London, United Kingdom; Mainz, Germany; Munich, Germany | full time | Job ID: 9160


As a Clinical Safety Specialist, you will support the execution of clinical safety and pharmacovigilance activities throughout the lifecycle of clinical trials. You will contribute to safety case processing, regulatory reporting, documentation, and periodic analyses of safety data.


Your main responsibilities are:
  • Contribute to clinical safety planning activities during trial set-up by supporting the preparation of safety management plans, charters, and reconciliation processes. Support in the coordination of cross-functional teams to enable readiness for safety data handling and reporting. Contribute to meeting organization (e.g. SMT, IRC, SRC) ensuring documentation of decisions and follow-up activities under the guidance of the Safety Manager.
  • May take on the day-to-day clinical safety responsibilities for an assigned clinical trial under the supervision of a Clinical Safety Scientist of Clinical Safety Manager.
  • Perform and support end-to-end case processing activities including data entry, case triage, MedDRA coding, causality and seriousness assessments, and safety query generation. Support the coordination of case exchanges with partners and contribute to the tracking of compliance metrics for safety reports.
  • Contribute to the preparation and quality review of SUSAR submissions, DSURs, line listings, and other periodic reports in accordance with global requirements and regional timelines.
  • Maintain accurate records within the safety database, support database testing activities (e.g., user acceptance testing), and assist with system issue resolution and enhancement requests.
  • Perform SAE reconciliation activities at the trial level, ensuring completeness and accuracy across clinical and safety databases.
  • Work closely with Safety Physicians and Safety Scientists to support the medical review of safety cases, contribute to safety data interpretation, and ensure consistency and accuracy in trial-specific documents such as clinical trial protocols and regulatory responses.
  • May participate in routine signal detection activities by compiling and formatting data for safety reviews under the supervision of the Clinical Safety Scientist or Safety Physician.

What you have to offer:

  • Bachelor’s Degree in life sciences, pharmacy, public health or a related field (postgraduate qualification preferred)
  • Minimum 2 years of experience in clinical safety and pharmacovigilance within the pharmaceutical, biotech, or CRO industry
  • Minimum 1 year of case processing experience
  • Knowledge of applicable regulatory, GCP, and GVP requirements in major geographies
  • Solid project management and cross-functional collaboration skills
  • Fluent in written and spoken English

Your Benefits:


It's our priority to support you:

  • Your flexibility: flexible hours | vacation account
  • Your growth: Digital Learning | Performance & talent development | leadership development | Apprenticeships | LinkedIn Learning
  • Your value: Your voice at the table | Culture on an equal footing | Opportunities to shape & impact | Support for your full potential
  • Your health and lifestyle: Company bike
  • Your mobility: Job ticket | Deutschlandticket
  • Your life phases: Employer-funded pension | Childcare

Apply now - We look forward to your application!


Apply to our London, United Kingdom; Mainz, Germany; Munich, Germany location by sending us your documents via our online form. For any questions, contact our talent acquisition team on: + 49 (0) 6131-9084-1291 (Monday-Friday from 12 PM to 4 PM CET).


Job ID 9160 (please always specify if you have any questions)


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.


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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!

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