Scope of Pharmacovigilance

• Improve patient care and safety in relation to the use of medicines, and all medical and paramedical interventions
• Improve public health and safety in relation to the use of medicines.
• Contribute to the assessment of benefit, harm, effectiveness and risk of medicines, encouraging their safe, rational and more effective(including cost effective) use, and
• Promote understanding , education and clinical training in pharmacovigilance and its effective communication to the public
• Humanitarian concerns
• Economical concerns
• At the time of approval, clinical trial data are available on limited numbers of patients treated for relatively short periods
• Once product is marketed, large number of patients may be exposed, including 1.Patients with co-morbid illnesses 2.Patients using concomitant medications 3.Patients with chronic exposure
• After marketing, new safety information may become available 1.Through use of the product domestically or in other countries 2.Through use of other drugs in the same class i)From preclinical studies ii)From pharmacological studies iii)From controlled clinical trials

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.