COMPREHENSIVE REVIEW ON ROLE ARTIFICIAL INTELLIGENCE: A GAME CHANGER FOR PHARMACOVIGILANCE? Authors: Agarwal P , PARMAR K AND PATEL P*
ABSTRACT
This review explores the transformative potential of artificial intelligence (AI) in pharmacovigilance
(PV), the field of ensuring medication safety. AI promises to significantly improve risk management,
adverse drug event (ADE) detection, and signal identification. The ever-increasing volume of data from
individual case safety reports (ICSRs) necessitates new approaches. Traditional methods struggle to
keep pace, highlighting the critical need for AI-powered solutions.
AI has the potential to revolutionise the daily work of PV professionals and accelerate career
advancement. It can enhance both qualitative and quantitative aspects of PV, leading to more effective
drug safety practices. By enabling advanced medical strategies like personalized treatment, AI can
optimize the risk-benefit balance for patients. Additionally, AI can significantly improve signal
evaluation, validation, and prioritization within PV.
However, challenges remain. Legal restrictions, ethical considerations, and data quality issues require
careful attention. Despite these hurdles, the future of PV is undoubtedly intertwined with AI. As AI
integration progresses, we can expect substantial improvements in patient safety and pharmaceutical
development.
Keywords: Drug safety, Cognitive service, Pharmacology, Pharmacovigilance, Artificial
Intelligence Publication date: 01/10/2025 https://ijbpas.com/pdf/2025/October/MS_IJBPAS_2025_9526.pdfDownload PDFhttps://doi.org/10.31032/IJBPAS/2025/14.10.9526