ISSN: 2474-9214
Authors: Srija M* and Ramya D†
Pharmacovigilance is integral to ensuring the safety and efficacy of pharmaceutical products throughout their lifecycle. This review explores the essential components of pharmacovigilance, highlighting its role in monitoring adverse drug reactions (ADRs), detecting safety signals, and managing risks associated with medications. Key components include adverse event reporting systems, advanced signal detection methodologies utilizing artificial intelligence and real-world data, rigorous data management and evaluation processes, and compliance with regulatory requirements. Effective communication strategies ensure dissemination of safety information to healthcare professionals and the public, promoting informed decisionmaking and enhancing patient safety. Challenges such as data quality, regulatory adaptation, and global harmonization are discussed, alongside future directions aimed at improving pharmacovigilance practices. By continuously evolving to integrate technological advancements and global collaboration, pharmacovigilance contributes significantly to public health by maintaining the integrity and safety of pharmaceutical therapies worldwide.
Keywords: Pharmacovigilance; Adverse Drug Reactions (Adrs); Drug Safety; Signal Detection; Real-World Data (RWD); Regulatory Compliance; Risk Management; Drug Monitoring; Post-Marketing Surveillance; Pharmacovigilance Methodologies
