Role of AI In Pharmacovigilance and Drug Safety: A Review

  • Unique Paper ID: 179146
  • PageNo: 5748-5753
  • Abstract:
  • In 1961. the World Health Organization (WHO) has established the Pharmacovigilance (PV) program in response to the thalidomide disaster, for global drug monitoring. PV is the science and activity relating to the detection, assessment, understanding and prevention of adverse effect and any other drug related problems. The aim of PV is to improve patients care and safety in relation to the use of medicine and all medical and paramedical interventions. The program has broadened its concerns by including herbals, traditional and complementary medicines, blood products, medical devices, herbal vigilance, hemovigilance and materiovigilance. Drug safety is mitigation exercise in which ADRs caused by therapeutics drug biologicals or devices can be explore, prevent or minimized. PV is collecting a huge amount of data daily and it is a challenging task to process these vast collected data. Al holds potential to transform Pharmacovigilance and is effective to improve PV activities. Examples of Al applications in Pharmacovigilance include the use of disproportionality analysis to regulate drug event combinations with subsequent expansions to drug-drug interactions and risk factors, syndrome detection, predictive models for statistical signal detection and case triaging. Al aim to achieve efficiency, quality and capability of drug in Pharmacovigilance.

Copyright & License

Copyright © 2026 Authors retain the copyright of this article. This article is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

BibTeX

@article{179146,
        author = {Tanu Priya and Prof Dr Kapil Kalra and Tanya Raj and Pragyanjali Lahon and Arpit Kumar and Deepak Rawat},
        title = {Role of AI In Pharmacovigilance and Drug Safety: A Review},
        journal = {International Journal of Innovative Research in Technology},
        year = {2025},
        volume = {11},
        number = {12},
        pages = {5748-5753},
        issn = {2349-6002},
        url = {https://ijirt.org/article?manuscript=179146},
        abstract = {In 1961. the World Health Organization (WHO) has established the Pharmacovigilance (PV) program in response to the thalidomide disaster, for global drug monitoring. PV is the science and activity relating to the detection, assessment, understanding and prevention of adverse effect and any other drug related problems. The aim of PV is to improve patients care and safety in relation to the use of medicine and all medical and paramedical interventions. The program has broadened its concerns by including herbals, traditional and complementary medicines, blood products, medical devices, herbal vigilance, hemovigilance and materiovigilance. Drug safety is mitigation exercise in which ADRs caused by therapeutics drug biologicals or devices can be explore, prevent or minimized. PV is collecting a huge amount of data daily and it is a challenging task to process these vast collected data. Al holds potential to transform Pharmacovigilance and is effective to improve PV activities. Examples of Al applications in Pharmacovigilance include the use of disproportionality analysis to regulate drug event combinations with subsequent expansions to drug-drug interactions and risk factors, syndrome detection, predictive models for statistical signal detection and case triaging. Al aim to achieve efficiency, quality and capability of drug in Pharmacovigilance.},
        keywords = {Pharmacovigilance, thalidomide, AI, detection, adverse effect},
        month = {May},
        }

Cite This Article

Priya, T., & Kalra, P. D. K., & Raj, T., & Lahon, P., & Kumar, A., & Rawat, D. (2025). Role of AI In Pharmacovigilance and Drug Safety: A Review. International Journal of Innovative Research in Technology (IJIRT), 11(12), 5748–5753.

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