AI enabled pharmacovigilance isn’t just about absorbing extra AE case volumes without driving up costs to maintain compliance and mitigate risk. It is also crucial to maximise the beneficial impact of important new products for patients. That’s as the industry continues to innovate and diversify, with novel therapies that could present broad scope for unanticipated side effects. If ever the conditions were ripe for AI’s assistance, that time is now, claims Qinecsa’s Adam Sherlock.
Pharmacovigilance (PV) demands have soared over the years, as the industry has championed new channels and generally made it easier for physicians, patients and carers to report potential adverse events (AEs) and other side effects linked to medicinal products prescribed, administered or supplied over the counter.
As volumes of generated AE cases have increased, the priority for those doing or funding the monitoring and case processing work has been to optimise these activities, to enable them to handle more adverse event (AE) cases for less. Outsourcing arrangements, and use of technology, have been geared largely to enabling those improved efficiencies.
Yet, as a growing range of critical new therapies and drug applications enter the market, with less predictable long-term effects, there are additional and more strategic priorities driving the PV technology agenda. Take GLP-1 receptor agonist/weight loss injections (WHO plans to officially support their use to treat obesity in adults[1]). Or messenger ribonucleic acid (mRNA) technology in approaches to cancer. And even the COVID-19 vaccines of 2020-2021, approved at speed for use by significant populations around the world[2] – populations that still need to be closely observed for emerging side-effects.
With new modalities and novel applications of medicines, there is a heightened imperative to detect issues and emerging patterns swiftly. This is compounding the need for technology-enabled PV transformation – as a means to hone accuracy, precision and speed, in addition to operational efficiency.
Could AI be a game-changer in pharmacovigilance?
It is in this wider context that artificial intelligence (AI) has begun to make its mark as a mature and viable solution to AE case processing. A number of AI solutions designed for pharmacovigilance are available now, and are now being put through their paces by leading pharma organisations, with promising results.
Already today AI-based PV tools have been shown to reliably handle large volumes of data, extract key information from various sources, and even detect subtle patterns that might be missed by human reviewers. (According to the US FDA, implementing AI in PV has improved the detection of potential drug risks by over 25%[3].)
The need for pharma companies to diversify as a means of new brand differentiation and long-term growth, on top of their already soaring AE case volumes, gives them little choice about harnessing next-generation, AI-driven process automation.
From inspiration to application: what’s needed to introduce pharmacovigilance AI?
The best approach to implementing AI will depend on a company’s existing pharmacovigilance ecosystem, the volumes of work it underpins, and the existing technology infrastructure that’s in place. However impressive the promise from the tech vendor, individual organisations will need to understand how a solution would fit their ‘as is’ set-up, and also how its deployment might translate into tangible benefits, including cost reduction and improved productivity.
Even for large pharma, with daunting AE case volumes to process, it isn’t just the scale of the operation that will determine the best path to AI use. Retiring legacy safety databases can be onerous, so implementing AI may require special wraparound software.
For organisations with more modest product portfolios, immediate PV pressures are more likely to revolve around limited internal resources, scalability and associated challenges with meeting AE reporting timescales in key markets. Here, the best approach initially may be to establish a digital-first capability starting with the inbound AE case capture process. The more that cases can be captured digitally at source, the greater the potential impact of AI in their assessment and processing.
Elevating PV’s influence
Whichever route companies take to advance their AE case processing capability, the goal should be to take action sooner rather than later – and to understand the more strategic benefits that are within reach. After all, while the significant scope for operational cost efficiencies will help support a strong initial business case, there is a lot more on offer here.
As more pharma companies look to novel and advanced products and therapies to drive new value for patients, and as a source of vital new growth, parallel advances in technology will help not only to streamline the pharmacovigilance function, but also to deliver important new insights that will enhance patient safety and inform future product development.
Underpinned by the right technology, the PV function could become a more strategic partner in drug development and product lifecycle management. That’s assuming there is integration with risk management and technology is leverage to streamline processes, surface new insights and hone decision-making.
Timely PV-driven insights could inform new studies to be considered for instance (in England, reports of pancreatic issues linked to weight-loss injections have triggered a new study into side effects of the treatments[4]); or identify potential new use cases for existing drugs for further exploration, following reports of unexpected side benefits. Taking the optimum AI route today will give companies’ their best chance to deliver on that vision.
About the author
Adam Sherlock, CEO of Qinecsa, is a deeply experienced pharmacovigilance strategist and leader, after more than three decades advising the life sciences industry. He has previously held CEO or senior leadership roles at Synapse Partnership, CSC, ProductLife Group, Kinapse (now part of Syneos Health), and Rephine.
References
[1] WHO to back use of weight-loss drugs for adults globally, raises cost issue, Reuters, May 2025: https://www.reuters.com/business/healthcare-pharmaceuticals/who-set-back-use-weight-loss-drugs-adults-globally-raises-cost-issue-2025-05-01/
[2] World Health Organization COVID dashboard: https://data.who.int/dashboards/covid19/vaccines
[3] Pharmacovigilance market, Market Research Future, June 2025: https://www.marketresearchfuture.com/reports/pharmacovigilance-market-8451
[4] Weight loss jabs study begins after reports of pancreas issues, BBC News, June 2025: https://www.bbc.co.uk/news/articles/c4ged0r1n3wo