PrimeVigilance’s Medical Team currently consists of 45 board-certified physicians. Some of our physicians have more than 20 years’ experience in the clinic and the pharmacovigilance arena. As a team we can cover all therapeutic areas and support clients in different tasks such as:
The development of risk management strategies to help on following up on important signals and development risk minimisation measures including the development of Post-Authorisation Safety Studies
Responses to Regulatory Authority requests, e.g. responding to EMA referrals
Benefit-Risk analyses, Clinical Expert Statements
Provision of therapeutic area and product training
Development and update of Reference Product Information.