Pharmacovigilance (PV) is undergoing a significant transformation, driven by advancements in Artificial Intelligence (AI). Ana Pedro Jesuíno, the Marketed Product Safety Associate Director at IQVIA, emphasizes that AI is now reshaping how safety data is managed, how signals are detected, and how compliance is upheld. As the volume of data and regulatory expectations continue to rise, AI is streamlining processes such as case intake and literature screening, while also enhancing aggregate reporting. Despite these benefits, the integration of AI into PV raises critical questions regarding trust and accountability.
Balancing Innovation and Regulatory Compliance
Regulatory bodies globally are heightening their scrutiny of AI systems to ensure they meet standards of fairness, transparency, and accountability. This involves practical expectations, such as requiring that AI systems are explainable and free from bias, to avoid compromising patient safety. For example, the European Medicines Agency’s Good Pharmacovigilance Practices (GVP) highlight the importance of vendor oversight and clear documentation. Similarly, the U.S. Food and Drug Administration (FDA) underscores that while automation enhances efficiency, human oversight remains essential.
As organizations integrate AI, they face the challenge of proving that their systems not only work effectively but are also validated and ethically supervised. Continuous inspection readiness is evolving from a one-time check into an ongoing requirement, necessitating proactive governance and transparent processes throughout the operational framework.
Leveraging Machine Intelligence for Data Management
The sheer volume of data encountered by PV professionals—from clinical trials to electronic health records and social media—renders manual review impractical. Here, machine learning plays a vital role in screening reports, identifying patterns, and flagging anomalies with greater speed. Yet, the interpretation of these findings still relies heavily on the expertise of PV professionals.
For instance, a patient stating, “I got a stomachache” carries a different weight than, “I got a stomachache that derailed my day.” The latter indicates a significant impact on quality of life that AI might not fully capture without human intervention. As regulatory standards evolve, PV teams must establish robust audit trails and quality checkpoints to ensure that automation complements compliance rather than undermines it.
Local Qualified Persons for Pharmacovigilance (LQPPVs) serve as essential connectors between global operations and local regulatory authorities. Their deep understanding of regional contexts allows them to interpret national requirements and ensure ongoing compliance. As pharmaceutical operations expand globally, LQPPVs play a crucial role in navigating complex regulatory landscapes, managing different reporting timelines, and respecting cultural nuances. Their expertise ensures that AI outputs are aligned with local laws, thereby maintaining patient safety and regulatory trust.
Ongoing oversight is becoming a differentiating factor in the industry. As AI-driven processes gain traction, organizations exhibiting sustained oversight will be better equipped to handle regulatory scrutiny. Collaboration between LQPPVs, regulatory bodies, and industry partners will shape best practices for AI validation and ethical deployment. This partnership will define how AI can be responsibly integrated into PV systems, ensuring patient safety and regulatory compliance are upheld.
The future of pharmacovigilance relies heavily on the decisions organizations make today. A successful strategy will combine advanced, validated technology with a strong governance framework that keeps PV teams at the forefront. By merging scalable AI with localized human expertise, companies can create harmonized global operations that are both compliant and resilient.
Ultimately, the purpose of pharmacovigilance is to protect patients. As technology evolves, the core principles of safety, transparency, and accountability remain paramount. Organizations that view AI not as a substitute for human vigilance, but as its most powerful ally, will be the ones to thrive in this new era of pharmacovigilance.
About Ana Pedro Jesuíno: With over ten years of experience in pharmacovigilance across both contract research organizations and the pharmaceutical industry, Ana Pedro Jesuíno leads IQVIA’s Local QPPV Global Network and holds a master’s degree in Pharmaceutical Sciences.
