Pharmacovigilance (PV) is undergoing a significant transformation as artificial intelligence (AI) becomes integral to managing safety data and compliance. In 2026, AI technology is reshaping the field by automating processes such as case intake and literature screening, promising enhanced efficiency when regulatory demands are at an all-time high. Yet, as organizations embrace these innovations, a critical challenge arises: maintaining trust with regulators while ensuring patient safety.
Ensuring Trust in AI-Powered Pharmacovigilance
Regulatory bodies worldwide are ramping up efforts to ensure that AI systems in pharmacovigilance not only perform effectively but also adhere to strict standards of fairness and accountability. For instance, the European Medicines Agency emphasizes the importance of ongoing vendor oversight and clear documentation within its Good Pharmacovigilance Practices (GVP). Similarly, the U.S. Food and Drug Administration (FDA) has highlighted that while automation enhances speed and scalability, human oversight remains crucial.
This dual focus on innovation and compliance is reshaping operational models within PV, pushing professionals to rethink their structural approaches. Organizations must now demonstrate that their AI systems are not only functional but also validated and ethically supervised. Consequently, continuous inspection readiness has evolved from a one-time requirement into an ongoing necessity, demanding proactive governance and transparent processes at every stage.
Addressing Increasing Data Volumes with Machine Intelligence
The volume of data in pharmacovigilance is expanding rapidly, encompassing everything from clinical trials to electronic health records and even social media. Manually reviewing this information is becoming increasingly impractical. Here, machine learning can play a pivotal role by screening reports, identifying patterns, and flagging anomalies more efficiently than human analysts.
Nevertheless, the human element remains irreplaceable in interpreting cultural nuances and clinical relevance. For example, a patient’s statement that “I got a stomachache” differs in implication from “I got a stomachache that derailed my day,” the latter indicating a more significant impact on quality of life. Such subtleties underscore the need for human validation in the oversight of AI processes.
As regulatory expectations evolve, PV teams are tasked with establishing audit trails and quality checkpoints. These measures ensure that automation strengthens compliance without compromising it, ultimately fostering efficiency and trust.
Local qualified persons for pharmacovigilance (LQPPVs) remain essential in this changing landscape. They serve as the vital link between global operations and local regulatory authorities. Armed with deep knowledge of regional contexts, LQPPVs help interpret national requirements, oversee vendor activities, and ensure inspection readiness.
The integration of AI must not jeopardize patient safety or regulatory trust, and LQPPVs play a critical role in maintaining this balance. Their expertise is particularly valuable in navigating complex regulatory environments, linguistic nuances, and varying cultural expectations across different markets.
Ongoing oversight and proactive compliance are now fundamental to successful pharmacovigilance. As AI-driven processes become commonplace, organizations that can demonstrate sustained oversight will be better positioned to respond to regulatory scrutiny. Collaborative efforts between LQPPVs and regulatory bodies will drive the development of best practices for AI validation and ethical deployment.
The future of pharmacovigilance hinges on organizations’ decisions regarding their current operational strategies. A robust approach will blend reliable technology with a solid governance framework that keeps PV professionals engaged. By leveraging scalable AI alongside localized human expertise, companies can avoid fragmented processes and instead create a harmonized operational model that is both compliant and resilient.
Ultimately, pharmacovigilance is dedicated to protecting patients. As technology evolves, the principles of safety, transparency, and accountability will remain paramount. Organizations that recognize AI as a powerful ally rather than a replacement for human vigilance will be positioned to thrive in this new landscape.
Ana Pedro Jesuino serves as the Marketed Product Safety Associate Director at IQVIA. With over ten years of experience in pharmacovigilance across 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.
