The future of pharmacovigilance – beginning the shift to AI-driven processes

In 2023, the pharmaceutical industry saw a surge in innovation. Propelled by the excitement around advanced technologies such as generative artificial intelligence (GenAI), many organisations turned to advanced automation to improve drug safety processes. Cutting-edge innovations were introduced that show promise to solve the challenges that pharmacovigilance (PV) teams face, enhancing efficiency and increasing the accuracy of operations.

However, it is unlikely that organisations will achieve implementation of these cutting-edge technologies in 2024. Rather, this coming year will be a critical turning point for the industry to revisit their existing PV models, explore potential capabilities and build trust in automated processes.

The current landscape

The traditional, long-lasting pain points of the PV space will persist into 2024. Caseloads will increase, widening the gap between workload and skilled workforce availability. This human-centric model is burdened by increased data volume and reduced workforce, which will make it difficult to meet demand. This can lead to compounding costs, staff burnout, and challenges in data management quality and accuracy.

Patient safety is a priority for drug safety operations, and data inaccuracies pose a substantial risk of harm. As volumes continue to grow and PV experts become scarce, organisations will be forced to re-evaluate their PV models to minimise patient risk and improve patient safety. Automation and advanced technologies will be critical tools to minimise these data quality issues through new methods of safety data processing, analysis, and reporting.

Overall, the industry recognises that automation will not just be a beneficial tool but a necessary one to address inconsistencies in existing processes, especially as requirements from regulators continue to shift and new, increasingly complex markets emerge. AI and machine learning (ML) can manage large data volumes more efficiently than the traditional, human-led PV processes; analytics can provide deeper insights into data that might otherwise be overlooked, enabling more precision in a timely manner. This manages costs and improves patient safety operations. The future of the PV space lies in embracing technologies such as generative AI and ML to improve accuracy and efficiency, and this shift will be evident in 2024.

A learning curve

There will be wide attempts to integrate AI into pharmaceutical safety processes, but full implementation is unlikely. Instead, 2024 will be a year of cautious exploration and advancement into the capabilities of AI and automation. This will be characterised by learning periods and gradual, phased adoption.

There must be a deeper understanding of the impact and change that these systems might bring, so that there are no surprises. This will entail rigorous evaluations in real-world scenarios to view the impact on operations and workflows. There will be trial-and-error experiences as each organisation evaluates the best uses of AI to meet their individual needs. While the excitement around technologies like generative AI will push for immediate integration into current drug safety processes, this will not be viable for sustainable, long-term operations.

The adoption of innovative tools into traditional, established PV systems will be challenging. The existing workflows may require an overhaul of processes to enable AI and automation. There are a variety of barriers to implementation, but building use cases and demonstrating the validity of automation is key. There is widespread scepticism of automated processes and caution around potential biases, so trust must be established prior to the incorporation of advanced technologies. Building trust in modern technologies will be a significant theme for the coming year – readiness to embrace innovation is pivotal to success. To properly integrate things like generative AI into drug safety processes, a careful and considered approach is not just highly advisable, but critical.

Organisations must address the concerns around AI-driven systems, while also demonstrating the benefits they bring to PV operations. This will require fostering a new mindset around embracing technologies, while still prioritising the highest standards of patient safety. Forward thinking and proactive risk identification will push the space forwards, driving the move towards a smarter way of working in PV, but this requires a cultural shift.

The future is automated

The PV sector is at an inflection point. The future demands automation and AI, but only as a fundamental aspect of long-term strategy. These tools can efficiently meet regulatory requirements, strengthen drug safety, and improve risk management, but the proper integration approach must be taken so that these technologies function correctly.

The increased innovation in the pharmaceutical industry in 2023 paved the way for the integration of advanced technologies like generative AI and automation in drug safety processes. While complete implementation may not occur in 2024, this year will be an important period for businesses to assess their current PV models and establish trust in automated procedures. Although there are challenges in integrating AI into traditional systems, the benefits in terms of efficiency, accuracy, and patient safety are clear. Automation is no longer a question of if but of when, and businesses that adopt these technologies early will be better positioned for future safe, reliable, and efficient PV systems.

About the authors

Updesh Dosanjh is a practice leader for the Technology Solutions business unit of IQVIA. In his role, Dosanjh is responsible for developing the overarching strategy regarding AI and ML as they relate to safety and pharmacovigilance. He has over 25 years of knowledge and experience in the management, development, implementation, and operation of processes and systems within the life sciences and other industries. Most recently, Dosanjh was with Foresight and joined IQVIA as a result of an acquisition. He holds a Bachelor’s degree in Materials Science from Manchester University and a Master’s in Advanced Manufacturing Systems and Technology from Liverpool University.

Michael De Jong is a VP and global head of PV and Regulatory Technology Professional Services at IQVIA. He has 30+ years of experience delivering process, technology, and organisational improvements spanning life sciences, technology, aerospace, and government industries. De Jong spent the last two decades working exclusively with pharmaceutical companies to improve the following business units/functions: pharmacovigilance, product labelling and packaging, clinical trial monitoring, and product development governance. Prior to his current role at IQVIA, De Jong led and managed several global process improvement and technology-services client engagements to achieve significant improvements in business performance while employed at Foresight Group International AG, WCI (now Navitas Life Sciences), Accenture, and PricewaterhouseCoopers.