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

Journal: Expert opinion on drug safety
Published Date: Aug 8, 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.

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. vera.battini@unimi.it.
  • 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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