Pharmacovigilance is the science of detecting, evaluating, understanding and preventing of long and short term side effects of medicines especially the adverse ones. The fundamental objectives of this stream of science are to identify new hazard information of medicines and prevention of harm to end users or patients. Usually commencing from clinical stage, it continues throughout the drug’s lifecycle.
Information is gathered during clinical trial (i.e.) drug pre-approval stage and goes on until post market safety research.
A product’s sponsor develops a pharmacovigilance plan specifically to detect new safety risks and/or assess already determined safety risks.
As per Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment guidelines laid down by the FDA, pharmacovogilance plans are appropriate where serious safety risks have been determined pre or post approval and/or where population at risk have not been adequately researched.