Pharmacovigilance (PV) is the science and process of detecting, assessing, understanding, and preventing adverse effects or other safety problems related to medicinal products.
PV activities include adverse event case processing, signal detection, aggregate reporting, risk management planning, and safety governance across development and post-approval use. In clinical development, PV ensures safety data are captured consistently across sites and reported within required timelines to regulators and stakeholders. PV findings can drive protocol changes, consent updates, enhanced monitoring, or product labeling updates. Robust PV programs protect participants and support regulatory confidence by demonstrating proactive, data-driven safety oversight.