According to the World Health Organization, Pharmacovigilance is the science and practice of detecting, assessing, analyzing, and preventing adverse effects or any other drug-related problems.
An adverse reaction, or ADR, is an unpleasant and unanticipated response to medicine that occurs at dosages routinely employed in man for disease prevention, diagnosis, therapy, or modifying physiological function.
ADR must be collected to estimate the risk and benefit of medication to promote its responsible and safe usage. Good pharmacovigilance detects drug-related risks as soon as possible to minimize or avoid any potential drug-related harm.
An identified reporter, an identifiable patient, an adverse reaction, and a suspected product are the minimum requirements for reporting.