Development Safety Strategy Lead* (Pharmacovigilance)

  • Mainz
  • Work experience
  • Medicine, Pharmacy, Laboratory
scheme imagescheme imagescheme image

Become a member of the BioNTech Family!

As a part of our team of more than 2.500 pioneers, you will play a key role in developing solutions for some of the most crucial scientific challenges of our age. Within less than a year, we were able to develop our COVID-19 mRNA vaccine following the highest scientific and ethical standards – writing medical history.
 
We aim to reduce the suffering of people with life-changing therapies by harnessing the potential of the immune system to develop novel therapies against cancer and infectious diseases. While doing so, we are guided by our three company values: united, innovative, passionate. 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.

Development Safety Strategy Lead* (Pharmacovigilance)

In this role, you are responsible for driving the Development Safety Strategy and monitoring the benefit-risk profile of assigned development products or programs, perform risk management and signal management activities and support safety writing activities.
Your main responsibilities are:
  • Drive the Development Safety Strategy of assigned development products or programs
  • Act as a member of the development core team, providing Development Safety Strategy input into the integrated development plan of assigned products or programs
  • Oversee the benefit-risk profile of assigned development products or programs
  • Perform signal management and risk management activities in compliance with global regulations and quality standards, as well as BioNTech’s SOPs
  • Provide medical expertise related to Development Safety Strategy aspects for the assigned products or programs and associated essential clinical trial documents (clinical study protocols and reports, CRFs, IBs, Safety Management Plans, DSURs)

What you have to offer.

  • Medical degree plus at least 5 years of experience in clinical safety or clinical development within the pharmaceutical industry or biotech
  • Expert knowledge of GCP, GVP and global applicable regulatory safety requirements
  • Experience in working in matrix organizations of multidisciplinary development teams
  • Experience in analyzing safety data from clinical trials in an aggregate manner and identifying and managing identified safety signals and risks and judging their potential impact in ongoing clinical development programs
  • Experience in interacting with Health Authorities and participation in and contribution to Scientific Advice Meetings
  • Expertise in writing / reviewing of safety sections in essential clinical trial documents
  • Experience with biologicals, vaccines, ATMPs or cell & gene, in the areas of oncology or infectious diseases
  • Experience in working with CROs and development partners
  • Strategic thinker; proven team player
  • Excellent English writing skills

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