Enliven: Pharmacovigilance and Drug Safety

Role of Pharmacovigilance in Drug Development
Author(s): Lekha Saha

Pharmacovigilance (PV) is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug related problem. PV collects, records, codes ADEs/ADRs analyses and assesses the reports, promotes the safe use of drugs, creates appropriate structures and means of communication needed to perform its tasks. The aims of PV are to improve patient care and safety, improve public health and safety, contribute to the assessment of benefit, harm, effectiveness and risk of medicines, promote education and clinical training, promote effective communication to public and promote rational and safe use of medicines.