Head* of Safety Evaluation & Risk Management

  • Mainz
  • Senior, very experienced
  • Medicine, Pharmacy, Laboratory
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Become a member of the BioNTech Family!

As a part of our team of more than 1.500 pioneers, you will play a key role in developing solutions for some of the most crucial scientific challenges of our age: Amongst multiple programs in the pipeline, we are conducting research on a Covid-19 vaccine in our project “Lightspeed” based on our mRNA-technologies. Furthermore, we are pioneers in the development of individualized cancer therapies and in the combat against other diseases.
 
We aim to achieve life-changing successes for patients by being innovative, passionate and united,so get in touch with us if you are looking to be a part of creating hope for a healthy future in many people´s lives.

Head* of Safety Evaluation & Risk Management

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

Benefits for you.

  • Company Pension Scheme
  • Childcare
  • Jobticket
  • Company Bike
  • Leave Account
  • Fitness Courses
  • Mobile Office
  • Special Vacation
... and much more.

Have we kindled your pioneering spirit?

Then apply now for our location Mainz and simply send us your application documents using our online form.

If you have any further questions, Johanna Diehl will be happy to answer them on + 49 (0) 6131-9084-1291 (Monday - Friday, from 12 noon).


*BioNTech does not differentiate on the basis of gender, race or ethnicity, religion, color, sexual orientation or identity, disability, age and other protected statuses as given by applicable law. We are committed to creating a diverse environment and are proud to be an equal opportunity employer. Most important – it’s a match!

BioNTech - As unique as you

https://biontech.de