Manager/Sr. Manager, Global PV Operations

Manager/Sr. Manager, Global PV Operations

Ascendis Pharma

Copenhagen, Denmark

You will become responsible for PV Operations activities and also serve as the Deputy QPPV for Ascendis Pharma. Additionally, you will maintain an overview of the safety profiles of the company's medicinal products and any emerging safety concerns. You will join a dynamic team of PV professionals, and you will report directly to the Head of Global PV Operations.

Main areas of responsibility:

  • Support Study Management Teams (SMTs) as an active member representing PV Operations team;
  • Oversees the PV vendors/service providersas applicable including vendors for Patient Support Programs and Market Research Programs;
  • Perform job duties typically assigned to a Deputy QPPV to support the QPPV in maintaining the Pharmacovigilance (PV) systems in line with the requirements for human pharmaceutical products.

Criteria of success in the role will be to:

  • You hold a relevant academic degree - preferably a Bachelor’s degree in a health care field with relevant pharmaceutical industry experience in drug safety. You have several years of documented experience within Pharmacovigilance from the pharmaceutical industry. Furthermore expert knowledge of FDA safety regulations, ICH Guidelines, and other applicable regulatory guidance documents; working knowledge of global safety regulations is required;
  • You are proficient in English at a professional level, both written and spoken, and you master MS Office;
  • You are a highly motivated individual who enjoys being challenged and working in collaborative environments.

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© EuroJobsites 2021

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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