• Collaboration efforts aim to reduce manual burden of adverse event reporting, enable ethical AI use, and accelerate innovation in drug safety monitoring

• New AI in Safety & PV community of experts to focus on responsible AI adoption in pharmacovigilance workflows

• Pharmacovigilance systems & processes standards project to establish interoperability and integration requirements, backed by Novo Nordisk, AbbVie, and Novartis

The Pistoia Alliance, a global not-for-profit alliance focused on collaborative life sciences R&D, today announced two new initiatives targeting pharmacovigilance (PV) challenges. In response to growing member demand, the Alliance is launching an AI in Safety & PV community of experts (CoE) to explore ethical, effective use of AI within PV workflows. Simultaneously, the pharmacovigilance systems & processes standards (PS²) project will create standardized software and integration requirements designed to reduce duplicated efforts and foster innovation in PV workflows through AI.

Pharmaceutical companies face increasing data volumes, with some PV teams managing over one million adverse event reports annually. Regulatory requirements now extend monitoring across diverse sources such as social media, patient support programs, and call center data. While AI offers promise for automating data capture and analysis, the reliability of AI-generated outputs remains a significant concern.

The AI in Safety & PV CoE will convene industry experts to address these risks, focusing on responsible adoption of AI technologies, from automated adverse event extraction to causality assessments. The PS² project will initially target the resource-intensive case intake process, aiming to standardize requirements and foster greater interoperability. Currently, the PV software market is fragmented, dominated by monolithic systems that are costly and resistant to innovation. Many organizations duplicate efforts building custom modules to meet similar needs.

The Alliance seeks additional funding and expertise from life sciences and technology companies to expand these initiatives and deliver practical solutions benefiting the wider late-stage R&D ecosystem.