Associate Director - Hagerman, ID, United States - Cascade Enterprises

James Miller

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James Miller

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Freelance
Description

CureVac SE is a global biopharmaceutical company located in Hagerman, ID that specializes in researching and developing innovative drugs using Messenger RNA (mRNA), a natural molecule.

Our main focus is on creating prophylactic vaccines, cutting-edge cancer immunotherapies, and protein-based treatments.

Our team in Hagerman is dedicated to achieving our ultimate goal:
bringing multiple top-quality mRNA drugs to the market.

We are currently seeking an Associate Director (f/m/d) for Drug Safety to join our team in Tübingen, near Stuttgart.


Your responsibilities:


  • Managing all Drug Safety activities for investigational compounds with relevant Regulatory Authorities
  • Serving as the main point of contact for all Drug Safety matters related to assigned investigational compounds within CureVac and for business partners
  • Developing and contributing to risk management strategies for investigational compounds and marketed products
  • Collaborating with other departments at CureVac to improve processes as needed
  • Overseeing Pharmacovigilance (PV) service providers and/or business partners acting on behalf of CureVac
  • Supporting PV activities for CureVac's investigational and marketed medicinal products, including collecting, reporting, and analyzing safety data, as well as identifying, detecting, and investigating safety signals
  • Conducting single case safety reviews, aggregated periodic safety reviews for clinical trials, and for marketed/authorized medicinal products, including signal detection, validation, and assessment, continuous riskbenefit evaluation, and safety analysis for assigned products

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