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Inside the Minds of Pharmacovigilance Leaders

01 Feb 2024
In an ever-changing world of drug safety and Pharmacovigilance (PV), one question stands as a guiding beacon: What transformative forces shape the horizon of patient safety? With this blog, we will try to give you a unique glimpse into the future of PV through the eyes of industry leaders.
This blog captures insights from our recent endeavors, encompassing a two-part webinar series on Generative AI (Gen AI), a survey within the PV industry, and the inaugural meeting of Indegene's Pharmacovigilance Digital Council.
Pharmacovigilance Digital Council is a global forum for leaders in PV to connect, learn, and share best practices and to help them modernize the patient safety function.
Expecting Tangible Benefits with Automation
From the overall discussion within the PV Digital Council, it is apparent that digital transformation in PV is seen as a game-changer, enhancing efficiency and data-driven decision-making. PV Leaders are focused on the trends, opportunities, challenges, and strategies for adopting digital technologies in PV, especially in case processing, signal detection, and benefit-risk assessment. There has been considerable attention on harnessing automation to enhance PV efficiency, quality, compliance, and inspection readiness, as well as how to measure and communicate the value of automation to senior management and other stakeholders. Unsurprisingly, there is a lot of curiosity around the potential of Gen AI and other emerging technologies to enhance signal detection and benefit-risk assessment and to enable proactive and cross-functional safety insights. PV leaders feel that the opportunity lies in automating repetitive tasks within signal detection, enabling teams to focus on nuanced analyses and strategic decisions.
Embarking on the Digital Trek
Interviews and discussions with industry leaders unveiled a consensus: digitalization is no longer a luxury but a necessity. As medical data burgeons in diversity and volume, technological advancements accelerate, prompting a pivotal moment where traditional approaches falter. The concept of "fit-for-purpose technology" is emerging as a guiding principle. Recognizing that not every pharmaceutical company requires AI, the emphasis shifts towards embracing technology through RPAs (Robotic Process Automation), rule-based systems, and other tailored solutions. This nuanced approach ensures that technology integration aligns with specific needs, fostering efficiency without unnecessary complexity. While some have embraced this transformation, the industry as a whole stands at the precipice of a digital revolution in PV. Indegene's recent survey conducted with 100 PV professionals echoes this sentiment. When asked about technology's potential to drive superior outcomes in PV, the majority—45%—expect mid-level efficiencies, while an astounding 61% foresee its scalability benefits (Figure 1).
The Next Frontier: Gen AI's Potential Unveiled
Amidst the discussions, Gen AI captivates industry experts. Envisioning its role in signal detection and benefit-risk assessment, curiosity abounds. AI is the linchpin in navigating vast data landscapes, offering insights beyond human capabilities. AI's evolution in PV reveals its role as a catalyst for advancing proactive safety insights, working in synergy with human expertise rather than displacing it. This deduction stems from discussions held during a webinar titled Unraveling the Potential of Generative AI (e.g., ChatGPT) in Pharmacovigilance, conducted around six months ago. A poll during the event to gauge the participants' familiarity with Gen AI revealed- that nearly one-third of the audience is actively adopting Gen AI at an organizational level or has experimented with its applications in their work, as illustrated in Figure 2. This finding underscores AI's growing integration and acceptance within the PV domain.
Recent developments in the global regulatory landscape are reshaping the AI narrative. The European Medicines Agency (EMA) has released a draft reflection paper as part of its Workplan 2022-2025, outlining perspectives on the use of artificial intelligence (AI) in the development, regulation, and use of human and veterinary medicines. Open for public consultation, the paper addresses principles relevant to AI and machine learning (ML) applications throughout a medicine's lifecycle. It emphasizes the potential benefits and challenges of AI/ML tools, covering areas from drug discovery to post-authorization activities. The document underscores the importance of a human-centric approach, ethical considerations, and compliance with legal requirements. The insights gathered will inform the finalization of the reflection paper and future guidance development. Simultaneously, the USFDA and Health Canada are progressing in implementing frameworks for AI-driven solutions.
These discussions are more than dialogues; they're beacons illuminating the path toward a digitally empowered, data-driven future in drug safety. As these innovations solidify, they promise a transformed PV landscape and a redefined healthcare paradigm.


Nikesh Shah
Nikesh Shah
Dr. Shubha Rao
Dr. Shubha Rao