Life Scientist as Director (m/f/d)

Das ist der Job

Lead implementation of safety risk management proc

Darum lohnt es sich

Director, Benefit Risk Management Cambridge, US; London, United Kingdom; Mainz, Germany; Munich, Germany | full time | Job ID:9209 The Director* Benefit Risk Management leads and maintains the global processes and governance for global and local safety risk management planning and for structured benefit-risk assessment (sBRA) in medical safety and pharmacovigilance to ensure patient safety and compliance with global regulatory and quality standards in alignment with company policies.

Act as benefit-risk lead and process expert as member of the Center of Excellence for benefit risk and risk management.

Guide safety management teams (SMTs) by moderating benefit-risk workshops, providing training on sBRA principles and best-practices, selection of data sources to evaluate safety data throughout product lifecycle across BNT\'s pipeline, in order to facilitate internal decision making as well as regulatory submissions.

To oversee structured benefit risk assessment and risk management activities for assigned BioNTech products through their development lifecycle management activities across multiple regulatory regions (EU,US, global) to ensure compliance with global regulatory and quality standards.

Provide guidance to SMTs on the selection of qualitative and quantitative sBRA methodologies and support the evolution from simple to complex evaluations from early to late product development, ensuring readiness for BLA/MAA submissions.