Director Pharmacovigilance & Risk Management

Director Pharmacovigilance & Risk Management

BioNTech

Mainz, Germany

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.

As the Director Pharmacovigilance & Risk Management, you will have the opportunity to formulate and implement regulatory strategies to support the development of several cutting-edge and personalized medicine technologies. Your main responsibilities are:

  • Set up and implement the next level-strategy for our global pharmacovigilance and safety operations for a portfolio of products/programs, ensuring the development of safety processes, tools and system implementation;
  • Strategically develop and implement post-marketing pharmacovigilance processes and contribute to the product specific Risk Management Plan;
  • Represent BioNTech on co-development teams for assigned products/programs and liaison with co-development partners to ensure coordinated safety reporting activities;
  • Provide guidance to product/program teams and CROs for safety case review and adjudication;
  • Participate in the review and interpretation of clinical trial results, particularly for understanding and interpretation of product safety.

What you have to offer

  • PhD, Doctorate or Master's Degree in one of the following areas: Medical (MD or equivalent), Nursing, Public Health or Pharmacy;
  • At least 10 years of experience in pharmacovigilance, product safety and/or clinical operations within the biotech, CRO or pharmaceutical industry;
  • Experience in designing or implementing safety reporting/safety management processes, systems and tools to support both case-level review and trend analyses;
  • Ability to implement product and study-level risk assessment and risk mitigation into global drug development;
  • Experience with oncology and/or rare disease product development, as well as analysis of biological treatments/ATMP is beneficial;
  • Knowledge and experience in signal detection methodologies;
  • Experience in managing teams responsible for safety operations and/or pharmacovigilance is required; readiness to take over QPPV responsibilities;
  • Expert knowledge of global safety reporting regulations, including US, EU, and UK requirements;
  • Knowledge in Regulatory audits and inspections, as well as management of partners and vendors.

Apply Now

Don't forget to mention EuroPharmaJobs when applying.

Share this Job

© EuroJobsites 2020

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

Newsletter | Recruit | Advertise | Privacy | Contact Us

© EuroJobsites 2020

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

This website uses cookies to make your experience better. Continued use of this website means you accept our cookie policy.  Accept Cookies