Associate Director - Drug Safety

Associate Director - Drug Safety

CureVac

Tübingen, Germany

Your responsibilities:

  • Fulfilling all Drug Safety activities for investigational compounds towards respective Regulatory Authorities;
  • Contact point for all Drug Safety matters for investigational compounds as assigned within CureVac and for business partners;
  • Develop and contribute to risk management strategies for investigational compounds and market products;
  • Collaborate with CureVac Interface departments to further strengthen processes as applicable;
  • Oversight of respective Pharmacovigilance (PV) service providers and/or business partner acting on behalf of CureVac;
  • Support PV activities for CureVacs’ investigational medicinal products (and market/authorised medicinal products) specifically in the collection, reporting and analyses of safety data; identifying, detecting and investigating safety signals;
  • Single case safety review, aggregated periodic safety review in clinical trials as well as for marketed/authorised medicinal products including signal detection, validation and assessment, continuous risk benefit evaluation, safety analysis for assigned products;
  • Support development of the PV quality assurance system required to ensure the company's compliance with respect to patient safety laws, regulations and guidance associated with the development and licensure of the company’s medicinal products;
  • Knowledge in and compliance with PV relevant regulations;
  • Support audits and Health authority inspections.

Your qualifications:

  • MD or Life Science degree or equivalent qualification;
  • Several years of experience as a Drug Safety professional with focus on clinical safety, but also PV background in pharma/biotech and/or CROs;
  • Independent working style but also a team player;
  • Strong communication and presentation skills;
  • Detail oriented way of working and problem solving and pragmatic attitude;
  • Flexible and used to changing priorities;
  • Fluency in English, German is a plus.

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© EuroJobsites 2022

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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