International Journal of Science, Engineering and TechnologyAuthors: Asila Sallauddin Shaikh
Abstract: Pharmacovigilance is a critical component of healthcare systems responsible for ensuring medicine safety through detection, assessment, understanding, and prevention of adverse drug reactions. Conventional approaches based on spontaneous reporting and manual evaluation face challenges including under-reporting, delayed signal detection, fragmented healthcare information, and limited predictive capability. This review explores the transformative role of Artificial Intelligence (AI) in Pharmacovigilance 5.0 by integrating machine learning, deep learning, natural language processing, predictive analytics, and real-world evidence. AI-driven systems have demonstrated potential in adverse drug reaction detection, safety signal identification, risk prediction, and regulatory decision support. The manuscript discusses emerging opportunities, technological frameworks, regulatory challenges, and future perspectives for establishing intelligent, predictive, and patient-centric drug safety surveillance systems.
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