Safety and Pharmacovigilance Professional

7 days ago


Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

About the Role

We are seeking an experienced Safety Surveillance and Rare Disease specialist to join our team at Novo Nordisk A/S. In this role, you will be responsible for leading and driving safety surveillance activities in development projects related to rare diseases.

The successful candidate will have a strong background in pharmacovigilance and safety surveillance, with experience working on development projects in rare diseases. You will work closely with cross-functional teams to ensure compliance with regulatory requirements and contribute to the establishment of the product safety profile during clinical development.

Responsibilities

  1. Chairing cross-functional drug safety committees to discuss emerging safety data
  2. Preparing communication about benefit-risk assessments to stakeholders
  3. Contributing to the development of clinical study designs and protocols
  4. Communicating with external parties related to clinical safety monitoring, such as Data Monitoring Committees
  5. Representing Safety Surveillance in cross-functional teams to drive collaboration and decision-making

Requirements

  • Several years of experience within Safety Surveillance and development in the pharmaceutical industry
  • A master's degree within Medicine or Natural Sciences, eventually complemented by a PhD/research experience
  • Interest/experience in data analysis and analysis tools (e.g., JMP and/or Qlik Sense)
  • Experience with rare diseases, hemophilia, or hemoglobinopathies is an advantage
  • The ability to work independently and collaborate in a dynamic environment
  • Strong skills in establishing contacts and collaborating with stakeholders in the organisation and externally


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