Artificial intelligence in pharmacovigilance signal management: a review of tools, implementations, research, and regulatory landscape.

Journal: Expert opinion on drug safety
Published Date: Aug 13, 2025

Abstract

INTRODUCTION: The integration of artificial intelligence (AI) into pharmacovigilance (PV) has advanced rapidly in recent years. AI tools have the potential to transform signal management by enabling faster and more accurate signal management and decision-making. However, the regulatory landscape governing these technologies remains complex. AREAS COVERED: This article presents available AI tools for signal management, provides an overview of the regulatory landscape of these tools, and explores stakeholder perspectives on the challenges and opportunities posed by AI regulations. On 23 July 2024, we conducted a Google search of the top 2,000 results using the query 'AI pharmacovigilance service provider.' Two searches were performed in Ovid MEDLINE to identify articles published between 1 January 2022, and 23 July 2024, using ad hoc queries. EXPERT OPINION: AI tools are now available to support all critical activities in signal management. However, regulatory discrepancies and variations persist across different regions. The findings underscore the urgent need for ongoing international collaboration to harmonize regulatory frameworks and ensure the safe and ethical implementation of AI in PV. As AI technologies continue to evolve, addressing these regulatory and operational challenges will be essential to fully realize their potential in enhancing drug safety and improving healthcare outcomes worldwide.

Authors

  • Maria Antonietta Barbieri
    Department of Drug Design and Pharmacology, University of Copenhagen, Jagtvej 160, 2100, Copenhagen, Denmark.
  • Vera Battini
    Department of Drug Design and Pharmacology, University of Copenhagen, Jagtvej 160, 2100, Copenhagen, Denmark. [email protected].
  • Carla Carnovale
    Pharmacovigilance and Clinical Research, International Centre for Pesticides and Health Risk Prevention, Department of Biomedical and Clinical Sciences (DIBIC), ASST Fatebenefratelli, Sacco University Hospital, Università degli Studi di Milano, Milan, Italy.
  • Marianna Cocco
    Department of Drug Design and Pharmacology, University of Copenhagen, Jagtvej 160, 2100, Copenhagen, Denmark.
  • Despoina Georgia Papoutsi
    Department of Drug Design and Pharmacology, University of Copenhagen, Denmark.
  • Nicole Sonne Heckmann
    Department of Drug Design and Pharmacology, University of Copenhagen, Denmark.
  • Guojun Dong
    Department of Drug Design and Pharmacology, University of Copenhagen, Jagtvej 160, 2100, Copenhagen, Denmark.
  • Andrea Rossi
    ASST Spedali Civili di Brescia, Ospedale dei Bambini, Brescia, Italy.
  • Simay Peker
    Department of Drug Design and Pharmacology, University of Copenhagen, Denmark.
  • Robbert P Van Manen
    Signalman Safety Consulting, Zeeland.
  • Sameer Thapar
    Oracle Life Sciences Center of Excellence, Oracle, USA.
  • Maurizio Sessa
    Department of Drug Design and Pharmacology, Drug Safety Group, University of Copenhagen, Copenhagen, Denmark.

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