The pharmacovigilance specialist role at Novo Nordisk – nested within the R&D Global Safety Department - exists to ensure the safety of patients using our pharmaceutical products, both during our clinical trials and while our products are on the market. By expertly performing safety data analysis and medical evaluations, pharmacovigilance specialists play a crucial role in the success of clinical trials and ultimately the availability of safe and effective medicines to patients around the world.

The work of pharmacovigilance specialists is primarily carried out in project groups, whereby pharmacovigilance specialists collaborate with colleagues and stakeholders to ensure key safety elements are brought forward when designing trial protocol and product labels.

Pharmacovigilance specialists use the latest technologies, combined with their expertise on the product and its therapeutic area, to ensure a favourable benefit-risk profile of our products.

Our current team is made up of approximately 100 professionals with various backgrounds, including medical doctors, veterinarians, pharmacists, and biologists.

Through analysis of safety data - primarily side effect cases - our team works to identify any clusters or trends that are occurring from the use of Novo Nordisk products. They then medically evaluate these cases, to determine if the side effect is related to our product, the patient’s existing disease or other products the patient is taking.

Their findings are then presented to a committee of senior experts, where the data will be challenged and validated. During audits and inspections, specialists are expected to take the lead on answering questions and providing any necessary information.

Specialists are responsible for contributing to several scientific documents – including the clinical risk management plan (RMP) – which is required during the marketing authorisation and clinical trial application processes. 

Ideally, physicians have clinical experience and our non-physicians have a strong background in pharmacovigilance. We hold our specialists to the highest ethical standards, and we actively seek qualified and collaborative candidates that are proactive, well-organised, and driven. 

Our team members get the rare opportunity to be a part of a truly global workplace, promoting medical advancement and patient safety.