#40 How to use artificial intelligence in pharmacovigilance, part 1 – Niklas Norén

Send a text message to the show!Far from a future add-on, artificial intelligence is already embedded in the cycle of drug safety, from case processing to signal detection. Versatile generative AI models have raised the bar of possibilities, but they have also increased the stakes. How do we use them without losing trust and where do we set the limits?In this two-part episode, Niklas Norén, head of Research at Uppsala Monitoring Centre, unpacks how artificial intelligence can add value to pharmacovigilance and where it should – or shouldn’t – go next.Tune in to find out:Why pharmacovigilance needs specific AI guidelinesHow a risk-based approach to AI regulation worksWhere in the PV cycle is human oversight most neededWant to know more?Listen to the second part of the interview here.The CIOMS Working Group XIV published its recommendations for the use of AI in pharmacovigilance in December 2025.Earlier this year, the World Health Organization issued guidance on large multi-modal models – a type of generative AI – when used in healthcare.Niklas has spoken extensively on the potential and risks of AI in pharmacovigilance, including in this presentation at the University of Verona and in this Uppsala Reports article. His favourite definition of AI remains the one proposed by Jeffrey Aronson in Drug Safety.For more on maintaining trust in AI, revisit this interview with GSK’s Michael Glaser from the Drug Safety Matters archive.The AI methods developed by UMC and cited in the interview include: vigiMatch for duplicate detectionvigiGroup for clusteringvigiRank for signal detectionvigiGrade for case report completeness scoringWHODrug Koda for automated codingGot a story to share?We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, get in touch!About UMCUppsala Monitoring Centre promotes safer use of medicines and vaccines for everyone everywhere. Follow us on Facebook, LinkedIn, X, and Bluesky.