Pharmacovigilance (PV) is the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem. It is a critical, continuous process aimed at ensuring the safety of medicines throughout their entire lifecycle, from development (pre-approval) to post-marketing surveillance.
The core function of PV is to collect, analyze, and monitor Adverse Event (AE) reports submitted by healthcare professionals, patients, and other sources worldwide. By systematically analyzing this data, pharmacovigilance teams can identify previously unknown side effects, emerging safety signals, and changes in the risk-benefit profile of a product. Companies must adhere to strict regulatory requirements, submitting regular safety reports to authorities like the EMA and FDA. Modern PV is increasingly supported by Artificial Intelligence (AI) and Real-World Data (RWD) tools to process the massive volume of safety information, making it essential for maintaining patient safety and ensuring public trust in medicines.
