Head of Safety Evaluation & Risk Management
Head of Safety Evaluation & Risk Management
BioNTech
Mainz, Germany
You will be responsible for the development and maintenance of a high quality, compliant, efficient and value-adding system overseeing the benefit-risk profiles of BioNTech's medicinal products - both in development and after marketing authorisation - and for providing medical input into regulatory documents and responses to regulatory authorities.
Your main responsibilities are:
- Together with the Senior Director Pharmacovigilance & Risk Management: Set up and oversee BioNTech's medicinal product's safety governance system
- Ensure signal and risk management activities are established and are compliant with global regulations and quality standards for BioNTech clinical development programs and marketed products
- Establish and direct a team of qualified Pharmacovigilance professionals (internal and external) in the area of Safety Evaluation & Risk Management
- Provide key safety input into regulatory documents, including safety reports (e.g. DSURs, PSURs), RMPs, IBs, study protocols and reports, responses to regulatory authorities, and submission packages
- Medical Monitoring and Signal Management activities
What you have to offer:
- Physician with at least 5 years of experience in pharmacovigilance and product safety within the pharmaceutical industry, biotech or CRO
- Expert knowledge of global Pharmacovigilance regulations and processes/Pharmacovigilance experience with vaccines, oncology and/or rare disease product development, as well as analysis of biological treatments
- Experience with the Safety Evaluation of Clinical Studies (Phase I-III), as well as in establishing, designing and implementing safety evaluation processes, systems and tools globally
- Ability to establish, implement and execute product safety risk assessment tools and risk mitigation strategies for developmental & marketed products globally
- Knowledge and experience in signal detection methodologies
- Expert knowledge of global safety reporting regulations, including US, EU, and UK requirements
- Experience in PV audits and inspections, as well as oversight and management of development partners, third parties and vendors
- Leadership skills and management abilities with experience in supervision of scientific and medical personnel, as well as teams for drug safety operations and/or pharmacovigilance
Don't forget to mention EuroPharmaJobs when applying.
