Pharmacovigilance refers to the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects and other drug-related safety problems. Related to this general definition, the underlying objectives of pharmacovigilance are to prevent harm from adverse reactions in humans that arise from the use of health products within or outside the terms of marketing authorization and in relation to the life cycle of these health products.

The main goal of pharmacovigilance is thus to promote the safe and effective use of health products, in particular by providing timely information about the safety of health products to patients, health-care professionals, and the public. Pharmacovigilance is therefore an activity contributing to the protection of patients and maintaining public health.