Safety and Pharmacovigilance Professional
7 days ago
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
- Chairing cross-functional drug safety committees to discuss emerging safety data
- Preparing communication about benefit-risk assessments to stakeholders
- Contributing to the development of clinical study designs and protocols
- Communicating with external parties related to clinical safety monitoring, such as Data Monitoring Committees
- 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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