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Title: :  Artificial Intelligence in Pharmacovigilance: Transforming drug safety & adverse event monitoring
PaperId: :  26515
Published in:   International Journal Of Advance Research And Innovative Ideas In Education
Publisher:   IJARIIE
e-ISSN:   2395-4396
Volume/Issue:    Volume 11 Issue 3 2025
DUI:    16.0415/IJARIIE-26515
Licence: :   IJARIIE is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License.

Author NameAuthor Institute
Aditi Ashutosh MhasatkarVidyabharti College of Pharmacy, Amravati, Maharashtra
Amol V. SawaleVidyabharti College of Pharmacy, Amravati, Maharashtra
Dr. M. D. GameVidyabharti College of Pharmacy, Amravati, Maharashtra
Sharayu P. JadhavVidyabharti College of Pharmacy, Amravati, Maharashtra

Abstract

Pharmacy
Pharmacovigilance, artificial intelligence, machine- learning, adverse drug reactions
The integration of Artificial Intelligence (AI) in pharmacovigilance is revolutionizing the monitoring of drug safety and significantly contributing to public health protection. AI technologies such as machine learning (ML), natural language processing (NLP), and deep learning (DL) are transforming traditional pharmacovigilance methods by enhancing the efficiency, speed, and accuracy of adverse event (AE) detection and safety signal prioritization. These technologies enable the analysis of vast volumes of structured and unstructured data from various sources, including electronic health records, social media, clinical trials, and spontaneous reporting systems, which would be challenging for manual review. AI facilitates proactive risk management by utilizing predictive analytics to forecast potential safety issues before they become widespread, thereby supporting personalized safety assessments and aiding in the design of safer medications. This shift from reactive to proactive surveillance marks a significant advancement in the field. However, the adoption of AI in pharmacovigilance also introduces several scientific, technological, ethical, and regulatory challenges. These include the necessity for high-quality, diverse, and representative training datasets, protection of patient privacy, minimization of algorithmic bias, and the demand for transparency and explainability in AI decision-making. Addressing these challenges is essential for ensuring trust and compliance with regulatory standards. Looking ahead, future trends in AI-powered pharmacovigilance include the incorporation of multi-modal data sources, real-time surveillance systems, and the development of explainable AI models for more robust causality analysis. As innovation continues, the integration of AI holds tremendous potential to elevate drug safety monitoring, improve healthcare outcomes, and streamline regulatory decision-making processes. This study aims to explore these applications, benefits, challenges, and future prospects in depth.

Citations

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IJARIIE Aditi Ashutosh Mhasatkar, Amol V. Sawale, Dr. M. D. Game, and Sharayu P. Jadhav. "Artificial Intelligence in Pharmacovigilance: Transforming drug safety & adverse event monitoring" International Journal Of Advance Research And Innovative Ideas In Education Volume 11 Issue 3 2025 Page 597-608
MLA Aditi Ashutosh Mhasatkar, Amol V. Sawale, Dr. M. D. Game, and Sharayu P. Jadhav. "Artificial Intelligence in Pharmacovigilance: Transforming drug safety & adverse event monitoring." International Journal Of Advance Research And Innovative Ideas In Education 11.3(2025) : 597-608.
APA Aditi Ashutosh Mhasatkar, Amol V. Sawale, Dr. M. D. Game, & Sharayu P. Jadhav. (2025). Artificial Intelligence in Pharmacovigilance: Transforming drug safety & adverse event monitoring. International Journal Of Advance Research And Innovative Ideas In Education, 11(3), 597-608.
Chicago Aditi Ashutosh Mhasatkar, Amol V. Sawale, Dr. M. D. Game, and Sharayu P. Jadhav. "Artificial Intelligence in Pharmacovigilance: Transforming drug safety & adverse event monitoring." International Journal Of Advance Research And Innovative Ideas In Education 11, no. 3 (2025) : 597-608.
Oxford Aditi Ashutosh Mhasatkar, Amol V. Sawale, Dr. M. D. Game, and Sharayu P. Jadhav. 'Artificial Intelligence in Pharmacovigilance: Transforming drug safety & adverse event monitoring', International Journal Of Advance Research And Innovative Ideas In Education, vol. 11, no. 3, 2025, p. 597-608. Available from IJARIIE, https://ijariie.com/AdminUploadPdf/Artificial_Intelligence_in_Pharmacovigilance__Transforming_drug_safety___adverse_event_monitoring_ijariie26515.pdf (Accessed : 17 September 2025).
Harvard Aditi Ashutosh Mhasatkar, Amol V. Sawale, Dr. M. D. Game, and Sharayu P. Jadhav. (2025) 'Artificial Intelligence in Pharmacovigilance: Transforming drug safety & adverse event monitoring', International Journal Of Advance Research And Innovative Ideas In Education, 11(3), pp. 597-608IJARIIE [Online]. Available at: https://ijariie.com/AdminUploadPdf/Artificial_Intelligence_in_Pharmacovigilance__Transforming_drug_safety___adverse_event_monitoring_ijariie26515.pdf (Accessed : 17 September 2025)
IEEE Aditi Ashutosh Mhasatkar, Amol V. Sawale, Dr. M. D. Game, and Sharayu P. Jadhav, "Artificial Intelligence in Pharmacovigilance: Transforming drug safety & adverse event monitoring," International Journal Of Advance Research And Innovative Ideas In Education, vol. 11, no. 3, pp. 597-608, May-Jun 2025. [Online]. Available: https://ijariie.com/AdminUploadPdf/Artificial_Intelligence_in_Pharmacovigilance__Transforming_drug_safety___adverse_event_monitoring_ijariie26515.pdf [Accessed : 17 September 2025].
Turabian Aditi Ashutosh Mhasatkar, Amol V. Sawale, Dr. M. D. Game, and Sharayu P. Jadhav. "Artificial Intelligence in Pharmacovigilance: Transforming drug safety & adverse event monitoring." International Journal Of Advance Research And Innovative Ideas In Education [Online]. volume 11 number 3 (17 September 2025).
Vancouver Aditi Ashutosh Mhasatkar, Amol V. Sawale, Dr. M. D. Game, and Sharayu P. Jadhav. Artificial Intelligence in Pharmacovigilance: Transforming drug safety & adverse event monitoring. International Journal Of Advance Research And Innovative Ideas In Education [Internet]. 2025 [Cited : 17 September 2025]; 11(3) : 597-608. Available from: https://ijariie.com/AdminUploadPdf/Artificial_Intelligence_in_Pharmacovigilance__Transforming_drug_safety___adverse_event_monitoring_ijariie26515.pdf
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