Pharmacovigilance: A Review on Drug Safety and Monitoring

  • Unique Paper ID: 174978
  • PageNo: 1564-1567
  • Abstract:
  • Pharmacovigilance is a vital discipline in healthcare that ensures the safety and efficacy of pharmaceutical products by systematically detecting, assessing, understanding, and preventing adverse drug reactions (ADRs). It plays a fundamental role in safeguarding public health by continuously monitoring drugs throughout their lifecycle, from clinical trials to post-marketing surveillance. This review comprehensively explores the core principles of pharmacovigilance, including its various types, essential applications, and the significant regulatory frameworks that govern drug safety across different regions. A key focus of this paper is the impact of pharmacovigilance in real-world settings, where post-marketing surveillance is crucial for identifying previously unrecognized ADRs that may not have been detected during pre-approval clinical trials. By analyzing pharmacovigilance studies on specific drugs, this review highlights the necessity of ongoing monitoring and reporting mechanisms that contribute to improving patient safety and therapeutic outcomes. The role of healthcare professionals, pharmaceutical industries, and regulatory authorities in ensuring effective pharmacovigilance systems is also discussed. Moreover, the rapid advancements in technology, particularly the integration of artificial intelligence (AI), big data analytics, and machine learning, have significantly transformed pharmacovigilance practices. These modern tools have enhanced the efficiency and precision of ADR detection, enabling proactive risk assessment and early identification of potential drug-related hazards. As the field of pharmacovigilance continues to evolve, the adoption of innovative technologies and global collaborations remains crucial in reinforcing drug safety measures and minimizing risks associated with pharmaceutical therapies. By shedding light on the dynamic landscape of pharmacovigilance, this review underscores the indispensable need for continuous monitoring and stringent regulatory oversight to protect public health and ensure the safe use of medicines worldwide. Pharmacovigilance, the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug- related problems, is intrinsically linked to effective information management. The pivotal role of information in pharmacovigilance encompassing data collection, analysis, and dissemination for optimal patient safety. The foundation of pharmacovigilance lies in robust information system that facilitate the collection of adverse event reports from healthcare professionals, patients, and other stakeholder. The evolution of data sources, emphasizing the integration of electronic health records, wearable devices and real world evidence to enhance the depth and breadth of information available for analysis. Innovative technologies, including artificial intelligence and machine learning, are transforming pharmacovigilance by automating signal detection and predictive modeling. How those tools are utilized to sift through vast datasets, identifying potential safety concerns and aiding regulatory decision-making. Furthermore, the abstract delves into the importance of structured information sharing between regulatory agencies, pharmaceutical companies, healthcare providers. Timely transparent communication of safety information ensure a proactive response to emerging risk and enable the development of effective risk management strategies.

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{174978,
        author = {Dr. Allabaksha Shaikh and Shraddha Ganesh Dalvi},
        title = {Pharmacovigilance: A Review on Drug Safety and Monitoring},
        journal = {International Journal of Innovative Research in Technology},
        year = {2025},
        volume = {11},
        number = {11},
        pages = {1564-1567},
        issn = {2349-6002},
        url = {https://ijirt.org/article?manuscript=174978},
        abstract = {Pharmacovigilance is a vital discipline in healthcare that ensures the safety and efficacy of pharmaceutical products by systematically detecting, assessing, understanding, and preventing adverse drug reactions (ADRs). It plays a fundamental role in safeguarding public health by continuously monitoring drugs throughout their lifecycle, from clinical trials to post-marketing surveillance. This review comprehensively explores the core principles of pharmacovigilance, including its various types, essential applications, and the significant regulatory frameworks that govern drug safety across different regions.  
A key focus of this paper is the impact of pharmacovigilance in real-world settings, where post-marketing surveillance is crucial for identifying previously unrecognized ADRs that may not have been detected during pre-approval clinical trials. By analyzing pharmacovigilance studies on specific drugs, this review highlights the necessity of ongoing monitoring and reporting mechanisms that contribute to improving patient safety and therapeutic outcomes. The role of healthcare professionals, pharmaceutical industries, and regulatory authorities in ensuring effective pharmacovigilance systems is also discussed.  
Moreover, the rapid advancements in technology, particularly the integration of artificial intelligence (AI), big data analytics, and machine learning, have significantly transformed pharmacovigilance practices. These modern tools have enhanced the efficiency and precision of ADR detection, enabling proactive risk assessment and early identification of potential drug-related hazards. As the field of pharmacovigilance continues to evolve, the adoption of innovative technologies and global collaborations remains crucial in reinforcing drug safety measures and minimizing risks associated with pharmaceutical therapies.  
By shedding light on the dynamic landscape of pharmacovigilance, this review underscores the indispensable need for continuous monitoring and stringent regulatory oversight to protect public health and ensure the safe use of medicines worldwide. 
Pharmacovigilance, the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug- related problems, is intrinsically linked to effective information management. The pivotal role of information in pharmacovigilance encompassing data collection, analysis, and dissemination for optimal patient safety. The foundation of pharmacovigilance lies in robust information system that facilitate the collection of adverse event reports from healthcare professionals, patients, and other stakeholder. The evolution of data sources, emphasizing the integration of electronic health records, wearable devices and real world evidence to enhance the depth and breadth of information available for analysis. Innovative technologies, including artificial intelligence and machine learning, are transforming pharmacovigilance by automating signal detection and predictive modeling. How those tools are utilized to sift through vast datasets, identifying potential safety concerns and aiding regulatory decision-making. Furthermore, the abstract delves into the importance of structured information sharing between regulatory agencies, pharmaceutical companies, healthcare providers. Timely transparent communication of safety information ensure a proactive response to emerging risk and enable the development of effective risk management strategies.},
        keywords = {Pharmacovigilance, Drug Safety, Adverse Drug Reactions (ADRs), Post-Marketing Surveillance, Regulatory Frameworks, Artificial Intelligence, Big Data Analytics, Risk Assessment, Drug Monitoring, Patient Safety.},
        month = {April},
        }

Cite This Article

Shaikh, D. A., & Dalvi, S. G. (2025). Pharmacovigilance: A Review on Drug Safety and Monitoring. International Journal of Innovative Research in Technology (IJIRT), 11(11), 1564–1567.

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