International Journal of Scientific Research and Engineering Development

Drug safety monitoring and adverse event reporting play a vital role in maintaining the safety and effectiveness of medicines after they are introduced into clinical practice. Ongoing surveillance helps detect previously unknown or rare adverse effects, while prompt reporting of adverse events enables healthcare authorities to evaluate potential risks and take appropriate action. Compliance with regulatory requirements ensures that safety data are systematically collected, analyzed, and shared, supporting informed decision-making. Collectively, these pharmacovigilance activities enhance patient safety, encourage the responsible use of medicines, and contribute to continuous improvements in public healthAI-Driven Drug Safety MonitoringEnsuring Data Integrity: Maintaining high-quality, comprehensive datasets is crucial, as incomplete or inaccurate data can compromise the reliability of safety signals.Transparency of Algorithms: Developing models that are interpretable and explainable is essential for gaining trust among healthcare professionals and regulatory bodies.Ethical and Privacy Concerns: Safeguarding patient confidentiality and addressing ethical issues related to data use are vital in implementing AI solutions responsibly.Regulatory Approval and Validation: Achieving acceptance from regulatory agencies requires rigorous validation of AI tools to demonstrate safety, effectiveness, and reliability.

T Abhinov, Chinju R Punnen, T Abhilash, Shreya Soni,A Ravi Kumar, "A Review on Drug Safety Monitoring Adverse Aspects Reporting Pharmacovigillance AI Aspects" International Journal of Scientific Research and Engineering Development, V9(4): Page(1220-1257) July-August 2026. ISSN: 2581-7175. www.ijsred.com. Published by Scientific and Academic Research Publishing.