The pharmacovigilance profession is an ever-evolving discipline with a rich history and an exciting future. As it encompasses multiple areas of science and a range of activities, people with various backgrounds and talents are needed to collaborate on the challenging tasks. These tasks include making decisions under strict time pressure, using all sources of relevant information, reviewing the best available evidence, while operating in a highly regulated environment.
By defining roles that belong to the profession, we define the scope of the GPPC, and we can then continue with development of the competency guidelines. These would then become the basis for testing competency of candidates.
The roles suggested in this guideline are inspired by the pharmacovigilance job roles that exist today. We all recognize that exact job titles may differ among organizations, however, the actual competence required for the job may be standardized and common denominators may be found between the job roles. Therefore, this guideline works with the concept of professional roles.