Pharmacovigilance Manager

Pharmacovigilance Manager

BioNTech

Mainz, Germany

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

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© 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

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