Careers in Pharmacovigilance

• Medical assessors, the most common role for physicians, are mainly concerned with the assessment of scientific data supporting applications new drug and abridged applications, clinical trial start-up, variations, renewals, reclassifications and pharmacovigilance.
• Assessors can take on special projects relating to individual drugs or a class of drugs. This is often needed in pharmacovigilance where reviews of the safety aspects of a drug class may be triggered by a public health issue from one product in the class.
• Reviews can also be much broader, such as drugs and driving or the use of medicines in children.
• These reviews can be challenging, but are rewarding to carry out and always involve presentations to and advice from experts on advisory committees.
• There is always a European perspective to be brought to these issues and there may be opportunity for academic publications.
• Assessors may also be invited to work on a CPMP working party to produce a guideline, for example on drug development in a particular class.
• After their appointment medical assessors are expected to develop their regulatory knowledge and competencies across a number of therapeutic areas but they frequently come with experience in a particular medical specialty and their expertise is fully utilized. Perhaps one of the most prestigious roles is to be one of the two representatives to the CPMP.