Associate Director Safety Operations
Mainz, Germany; London, United Kingdom; Munich, Germany | full time | Job ID: 11913
About the role:
As Associate Director, Safety Operations, you connect pharmacovigilance requirements, systems, and service delivery across clinical development and post-marketing activities. Your work supports BioNTech’s mission by helping ensure safety information is managed accurately and in line with applicable requirements.
You’ll work with cross-functional teams, system vendors, and external service providers to improve safety processes and database capabilities. As Deputy Process Owner for the safety database, you’ll help turn business and regulatory needs into practical, coordinated changes.
Your contribution:
- Drive the development and continuous improvement of safety database processes, translating operational and regulatory needs into effective system changes
- Coordinate database enhancements with internal stakeholders and the system vendor, from prioritization and testing through rollout and ongoing improvement
- Oversee external providers of safety operations services to support quality, compliance, and reliable case processing and reporting
- Provide pharmacovigilance and database expertise for safety data analysis, study documents, periodic reports, and cross-functional activities
- Maintain key safety procedures and support audit and inspection readiness through clear, compliant processes and documentation
- Guide and train colleagues and service providers on safety operations processes and applicable pharmacovigilance requirements
A good match:
- Advanced degree in life sciences, healthcare, or a clinically relevant discipline; a PhD, PharmD, MPharm, or postdoctoral pharmacovigilance certification is preferred
- Experience in post-marketing pharmacovigilance and clinical research, including substantial exposure in biotechnology, pharmaceutical industry, or a contract research organization
- Experience overseeing safety database functionality and configuration, coordinating internal stakeholders and external vendors, and implementing safety processes and tools
- Knowledge of pharmacovigilance regulations, Good Clinical Practice, and Good Pharmacovigilance Practices, plus experience processing, assessing, and reporting clinical-trial and spontaneous safety data
- Fluent written and spoken English, with strong scientific and organizational communication and presentation skills
- A proactive, solution-oriented approach; you handle ambiguity with balance, influence stakeholders constructively, and uphold high ethical standards and safety data integrity
Your 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 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.
We are looking forward receiving your application.