White Paper

Enhancing Patient Safety: A Paradigm Shift Through Early AI Adoption in Pharmacovigilance Workflows

Enhancing Patient Safety: A Paradigm Shift Through Early AI Adoption in Pharmacovigilance Workflows

Pages 9 Pages

This IQVIA and Genentech white paper details the ATHENA initiative, which applies AI/ML earlier in pharmacovigilance workflows to improve adverse event detection. Traditional PV often starts at case processing, missing upstream opportunities, with only 1–10% of ADRs reported to the FDA. ATHENA leverages IQVIA Vigilance Detect, combining NLP, ontologies, and supervised learning to automate safety data review. Results include a 42% reduction in manual review, 90% efficiency gains, and 50% fewer invalid safety reports since 2019. Beyond efficiency, ATHENA enhances patient-centricity, freeing staff from administrative tasks and enabling more meaningful safety oversight.

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