Volume-2 ,Issue-9, September- 2026

Pharmacovigilance plays a pivotal role in ensuring the safety and efficacy of medicines throughout their lifecycle. With the increasing complexity of drug therapy, polypharmacy, and global drug distribution, monitoring adverse drug reactions (ADRs) has become a critical public health responsibility. This project explores pharmacovigilance as a systematic framework designed to detect, assess, understand, and prevent adverse effects or any other drug-related problems. Through an extensive review of published review articles and regulatory documents, this study synthesizes existing evidence on pharmacovigilance systems, reporting mechanisms, signal detection methodologies, and regulatory practices. Key challenges such as underreporting, lack of awareness among healthcare professionals, and limitations of spontaneous reporting systems are highlighted. The findings emphasize the need for strengthened pharmacovigilance infrastructure, improved reporting culture, and integration of advanced data analytics. The study concludes that a robust pharmacovigilance framework significantly contributes to safer therapeutic practices and improved patient outcomes.

Keyword: Pharmacovigilance, Adverse Drug Reactions, Drug Safety, Signal Detection, Risk Management, Patient Safety