Pharmacovigilance (PV) is the science and set of activities dedicated to the detection, assessment, understanding, and prevention of adverse effects or any other drugrelated problems. It is an essential component of public health, ensuring that the benefits of medications outweigh their risks. PV spans pre-marketing clinical trials, postmarketing surveillance, and the continuous reevaluation of drug safety profiles. Regulatory authorities such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and the World Health Organization (WHO) coordinate PV systems globally. The increasing complexity of modern therapies, including biologics and gene therapies, makes robust PV frameworks more crucial than ever.
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