Lucinda Smith- Chief Safety Product Officer, ArisGlobal
At the peak of the COVID-19 pandemic, the role of drug safety attracted unprecedented mainstream attention. As new vaccines entered the market, and as a spectrum of different treatments was applied, the ability to quickly and efficiently capture accurate data, spot trends, draw robust conclusions about emerging safety issues, and act on them promptly became tangible - and expected by the public.
Suddenly, whole generations had a first-hand appreciation of side effects at scale, and of the fundamental assumption that the products they take are safe. Lamentably, however, the pharma industry failed to capitalize on this opportunity to more permanently reframe pharmacovigilance (PV) and its scope for wider contribution to the drug development cycle.
An Overshadowed Opportunity
Drug safety’s core remit, to ensure optimal outcomes for patients, has become overshadowed by the rising expectations of regulators over the last couple of decades. As workloads have soared, the function has taken on a “cost center” status and become a target for significant streamlining – the goal being to enable the absorption of increasing workloads (e.g., around adverse event - AE - case processing) without adding costs.
To adjacent functions, meanwhile, Safety has (unfairly) found itself with a reputation as an inhibitor to new drug delivery - a conservative function always seeking additional assurances; an impediment to progress.
Along the way, something important has been lost. That is the extended value represented by Safety, by virtue of its insights, and through its expertise.
As products and therapies become more targeted and personalized, and expensive to develop, one of the challenges is to ensure that they are made available to as many applicable patients as possible. Earlier, more timely involvement from Safet would enable prompt identification and management of safety issues, at a point where valuable interventions can be made. That could include ‘killing’ unviable products at an earlier stage. All of this reduces the risk to patients and to the company and maximizes the reach and beneficial outcomes of the approved product.
Returning Safety’s Emphasis to Where It’s Really Needed
While Safety teams’ time is almost entirely consumed with the routine burden of manually processing AEs, authoring aggregate reports, and analyzing false signals, those professionals’ potential for strategic redeployment remains limited. It is why, in the light of soaring workloads, processes must be modernized - harnessing the latest technology.
Artificial intelligence (AI), especially Generative AI (GenAI) technology, can now readily streamline activities such as capturing AE information straight into a database. That’s as long as teams trust the output sufficiently. Where human experts are required to check everything, any productivity and cost-efficiency gains will be undermined. In more technologically advanced regulated industries like the financial services sector, advanced automation has been confidently applied to repeatable processes. This is largely thanks to appropriate governance and oversight, and adapted quality assurance measures, to verify any AI-supported output. The opportunity now is for pharma PV teams to adapt their own governance and quality processes, maximizing the resource liberation that AI technology offers them.
At the same time, Safety teams are understanding afresh the need to assert their voice. This is as a supporter not only of patient outcomes, but also of the business’s strategic interests, including a drug’s market success. The more that they can convey this potential, so that other internal groups see Safety as an ally (the way to get their products to market), the more influence they stand to gain. Where AEs can be anticipated in advance, there is a greater scope for the company to manage risk effectively. This could result in more products succeeding, or conversely, less financial exposure through waste (if a product can be killed earlier).
A national study in Italy published late last year, into the need for PV’s reinvention, highlighted the need for greater strategic alignment between the Safety function with business objectives and stakeholder focus - including those around patient centricity and biotech innovation. The optimal transition is likely to be two-way: whereby Safety teams embrace opportunities to better manage their time and use their voice in more influential ways, while adjacent internal functions become more open and receptive to the rounder value that Safety could bring to product advancement.
The Imperative for Change - and How to Deliver It
In the light of growing pressure to accelerate drug development and delivery cycles, pharma companies must now give new emphasis to managing the Safety data that is collected at each stage. This is not about capturing more of it for its own sake, but rather appreciating and seeking the optimal combination of data to support appropriate analysis - and to enable a rounded understanding of the safety profile.
Arriving at this point requires earlier collaboration and the development of trust between the groups, so that everyone is pulling in the same direction. With many products now going to market with much less clinical data than previously – particularly in a context of unmet medical needs - careful planning and close collaboration with local markets is essential. This is to ensure that on-market data is collected, assessed, and fed back quickly and effectively.
An additional contributor to change may come from companies’ expansion into medical device development, establishing a greenfield scenario for modern Safety/PV. Where existing processes and ways of working in PV have become complex over time, approaches to Safety for medical devices can be built from the ground up in a more connected, streamlined, and digital-first way. Any resulting best practices could then be transposed to entrenched pharma PV practices.
Whatever the current state of play, Safety leaders should be looking to make some changes now, even if initially these are small iterative improvements to processes – such as applying GenAI to enable automatic AE data extraction in Individual Case Safety Report (ICSR) work. Demonstrating incremental improvements in productivity, efficiency, and quality, and learning from them, will help spur progress, however modest at first. The more that advanced technologies can be leveraged to alleviate resource consumption and accelerate routine process delivery, the easier it will be for the Safety function to assume an elevated role - both in speaking up for patient priorities, and as an enabler of new drug advancement.
References
- Smith, L., Glaser, M., Kempf, D. et al. Might We Come Together on a Paradigm Shift to Manage ICSRs with a Decentralized Data Model? Drug Saf 48, 843–853 (2025). https://doi. org/10.1007/s40264-025-01539-4.
- The evolution of the Pharmacovigilance department in the pharmaceutical industry: results of an Italian national survey - research by the PV working group, Ernesto Montagna, of the Italian Society of Pharmaceutical Medicine (SIMeF ETS), National Library of Medicine (National Center for Biotechnology Information), November 2024: https://pmc.ncbi.nlm. nih.gov/articles/PMC11536373/
Author Biograph
Lucinda Smith is ArisGlobal’s new Chief Safety Product Officer, after more than two decades working in frontline scientific and strategic Pharmacovigilance and Drug Safety roles at a major pharma brand.
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