Associate Director Safety Data Analyst | Data Scientist (m/w/d)
Unknown Employer
Job Summary
This pivotal role involves serving as the primary contact for Safety Strategy Leads, Physicians, and Scientists within the Medical Safety and Pharmacovigilance department. The Associate Director will leverage expertise in strategic data analysis to transform complex safety datasets into actionable insights, crucial for regulatory submissions and shaping product safety profiles. Key responsibilities include preparing and presenting data-driven insights for signal management and benefit-risk assessments, and ensuring compliance with global regulatory standards (FDA, EMA, ICH). A significant part of the role is the implementation and continuous improvement of BioNTech's in-house safety analytics platform, driving data automation, and leveraging AI to enhance efficiency and accuracy in pharmacovigilance data assessments. This position offers the chance to lead innovative data solutions within a cutting-edge biotech environment.
Required Skills
Education
Master’s degree in life sciences, computational sciences, data sciences, or related fields (Doctorate preferred)
Experience
- Multiple years of experience in pharmaceutical/biotech data analysis
- Multiple years of experience in the pharmaceutical industry
- Proven expertise in conducting medical safety and pharmacovigilance data assessments within validated computer systems
- Strong knowledge of pharmacovigilance regulations (GCP, GVP) and FDA, EMA, and ICH guidelines
Languages
Additional
- Role is based in Mainz, Germany; London, United Kingdom; or Munich, Germany. Must align all activities with FDA, EMA, GCP, GVP, and ICH regulatory standards.