The field of pharmacovigilance (PV) is undergoing significant transformation as artificial intelligence (AI) becomes an integral part of safety data management. According to Ana Pedro Jesuíno, Marketed Product Safety Associate Director at IQVIA, AI is reshaping the landscape by automating processes such as case intake and literature screening. This shift comes at a time when the volume of data and regulatory demands are increasing substantially, highlighting the need for efficient and scalable solutions.
Balancing Innovation with Regulatory Trust
While AI holds great promise for enhancing operational efficiency, it also raises critical issues concerning trust and accountability. Regulatory bodies worldwide are tightening their expectations regarding transparency and oversight. As a result, PV teams are compelled to move beyond traditional compliance models and embrace adaptive, technology-enabled frameworks. This evolution necessitates a careful balance between innovation and responsibility to ensure that technology complements human judgment, ultimately safeguarding patient safety.
Regulatory agencies like the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) are leading the charge in setting standards for AI integration in PV. The EMA emphasizes ongoing vendor oversight and clear documentation, while the FDA maintains that, despite automation’s benefits, human oversight remains vital. Both agencies advocate for AI systems that are explainable, auditable, and free from bias, underscoring the need for a robust framework that supports ethical AI deployment.
Data Overload and the Role of Human Expertise
The vast amount of data flowing into PV—ranging from clinical trials to social media—makes manual analysis increasingly impractical. AI can assist by swiftly screening reports and identifying patterns, yet it is essential for PV professionals to validate these findings. Cultural nuances and emotional contexts play a crucial role in patient safety, as illustrated by the difference between a patient merely stating, “I got a stomachache,” and another saying, “I got a stomachache that derailed my day.” The latter reflects a more significant impact on quality of life, which AI might overlook without human input.
As regulatory expectations evolve, PV teams must establish comprehensive audit trails and quality checkpoints. This ensures that automation enhances compliance rather than hinders it, fostering both efficiency and trust. Local Qualified Persons for Pharmacovigilance (LQPPVs) serve as vital links between global operations and local regulatory requirements, ensuring adherence to regional laws and cultural contexts.
LQPPVs are uniquely positioned to monitor vendor performance, oversee literature, and maintain inspection readiness, which is critical as global pharmaceutical operations expand. Their expertise allows for a nuanced interpretation of AI outputs, ensuring that patient safety and regulatory integrity remain uncompromised.
As AI-driven processes become more prevalent, continuous compliance will be essential. Organizations demonstrating sustained oversight will be better equipped to manage regulatory scrutiny. Collaboration between LQPPVs, regulatory bodies, and industry partners will guide the establishment of best practices for AI validation and ethical deployment.
The future of pharmacovigilance hinges on the decisions made today regarding technology integration. A successful strategy will involve a combination of validated technology and a solid governance framework, ensuring that PV teams are actively engaged in the oversight process. By merging scalable AI capabilities with localized human expertise, organizations can create harmonized processes that are both compliant and resilient.
Ultimately, the primary goal of pharmacovigilance is to protect patients. As technology continues to advance, the core principles of safety, transparency, and accountability will remain crucial. Organizations that view AI not as a replacement for human vigilance but as a powerful ally will be poised to thrive in this new era of pharmacovigilance.
Ana Pedro Jesuíno has over ten years of experience in pharmacovigilance, including roles in both contract research organizations and the pharmaceutical industry. She oversees IQVIA’s Local QPPV Global Network and holds a master’s degree in Pharmaceutical Sciences.
