Pharmacovigilance is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem. Pharmacovigilance heavily focuses on adverse drug reactions, or ADRs, which are defined as any response to a drug which is noxious and unintended, including lack of efficacy.
- Analyse safety signals
- Recommend regulatory actions
- Communicate relevant safety information
- Adverse event reporting
- Individual Case Safety Report