Scientist Biology, Medicine, Pharmaceutics as Pharmacovigilance Manager - Clinical studies *

Everyone can achieve great things at BioNTech! We develop revolutionary approaches in the fight against cancer and other diseases. BioNTech wants to become the world’s leading biotechnology company for individualized cancer medicine. Over 1000 dedicated, passionate pioneers achieve sensational success and promising breakthroughs time and again by forging new paths – and ensure people all around the world have hope for the future. You too can become a pioneer!

Pharmacovigilance Manager*

Here, you’ll achieve greatness.

At BioNtech, your job will be to ensure that our clinical studies meet the regulatory requirements. In this way, you will be guaranteeing the early identification and evaluation of drug-related risks. Your duties in detail:
  • The execution and coordination of all pharmacovigilance processes in accordance with the regulatory requirements and applicable standard operating procedures (SOPs)
  • The preparation and maintenance of safety-relevant documentation for our clinical studies. The compilation of clinical study protocols and information for investigators (IBs)
  • The processing of cases of serious adverse events and production of legally compliant reports concerning suspected unexpected serious adverse reactions (SUSARs)
  • Coordination of the medical review of our clinical study data and validation of the MedDRA coding of the adverse events (AEs) documented in the studies
  • The prompt submission of our annual development safety update reports (DSURs), preparation and presentation of the relevant study data, compilation of the review and its prompt submission to official bodies and ethics commissions

What you have to offer.

  • A qualification in natural sciences (master’s/degree/doctorate) in biology, medicine, pharmaceutics or a comparable discipline; alternatively, medical training (e.g. as a medical documentalist*) with relevant practical experience
  • Some years of professional experience in the pharmacovigilance field in clinical studies
  • Sound knowledge of the relevant laws and regulatory requirements concerning pharmacovigilance in clinical studies; knowledge of the regulations governing the subsequent approval field is desirable
  • Ideally, experience in MedDRA coding
  • The ability to work independently and very good spoken and written English

Benefits for you.

  • Jobticket
  • Child Care
  • Company Bike
  • Fitness
  • Pension
  • Relocation
...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, Friederike Mangelsen 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, religion, color, origin, sexual orientation, disability, age and other protected status as required by applicable law. We are committed to creating a diverse environment and are proud to be an equal opportunity employer.
BioNTech - As unique as you

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About BioNTech SE

Bei BioNTech leistet jeder Großes! Denn als eines der am schnellsten wachsenden Biotechnologie-Unternehmen Europas arbeiten wir an revolutionären Ansätzen im Kampf gegen Krebs und andere Krankheiten. Über 1000 Pioniere, die mit viel Herzblut neue Wege beschreiten, schaffen immer wieder aufsehenerregende Erfolge und vielversprechende Durchbrüche – und sorgen dafür, dass Menschen rund um die Welt...
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