Pharmacovigilance (PV) is experiencing significant transformation through the integration of Artificial Intelligence (AI). As of 2026, AI technologies have moved beyond theoretical applications and are now actively reshaping safety data management, signal detection, and regulatory compliance. This evolution brings promising efficiencies and scalability, particularly as the volume of data and regulatory scrutiny continues to increase. Despite the advantages, the rise of AI also raises critical concerns around maintaining trust and accountability in regulatory environments.
Balancing Innovation with Regulatory Compliance
Regulatory authorities worldwide are tightening their oversight of AI systems, ensuring they meet rigorous standards of fairness, transparency, and accountability. These standards require that AI technologies be explainable, auditable, and free from biases that could endanger patient safety or mislead clinical decisions. For example, the European Medicines Agency has issued Good Pharmacovigilance Practices (GVP) guidelines, which stress the importance of ongoing vendor supervision, established escalation pathways, and meticulous documentation. Similarly, the U.S. Food and Drug Administration (FDA) has reaffirmed the necessity of human oversight, emphasizing that while automation can enhance speed and efficiency, it cannot replace the critical role of human judgment.
This evolving regulatory landscape is compelling PV teams to reassess their operational frameworks. Organizations must now demonstrate that their AI systems are not only effective but also validated and ethically managed. Continuous readiness for inspections is becoming a standard expectation, necessitating proactive governance and transparent processes throughout the pharmacovigilance lifecycle.
Harnessing Data Through Machine Learning
The sheer volume of information confronting PV professionals—from clinical trial data to electronic health records and social media—exceeds what can be processed manually. Machine learning offers a solution by enabling rapid screening of reports, detection of hidden patterns, and identification of anomalies with enhanced speed and accuracy. Yet, human expertise remains essential in interpreting these findings, particularly regarding cultural contexts and clinical relevance.
For instance, consider two patient statements: “I got a stomachache” versus “I got a stomachache that derailed my day.” The latter implies a greater impact on quality of life—an insight that AI might overlook without human intervention. As regulatory expectations shift, PV teams are tasked with creating thorough audit trails and quality checkpoints to ensure that the benefits of automation do not come at the cost of compliance and trust.
Local qualified persons for pharmacovigilance (LQPPVs) play a pivotal role in this new landscape. They serve as vital links between global operations and local regulatory bodies, leveraging their regional knowledge to navigate complex legal environments and varying cultural expectations. As pharmaceutical companies expand their global reach, LQPPVs will be instrumental in interpreting AI outputs considering local laws, ensuring that patient safety and regulatory trust are upheld.
Continuous Oversight and Ethical AI Deployment
In the current climate, compliance is no longer a one-time achievement; it requires continuous and proactive measures. Organizations that can maintain sustained oversight of AI-driven processes will be better positioned to navigate regulatory scrutiny. Collaboration between LQPPVs and regulatory authorities is essential for developing best practices in AI validation and ethical deployment. This partnership will define how AI can be integrated into PV systems while safeguarding patient safety and compliance.
The decisions made today regarding AI integration will shape the future of pharmacovigilance and the trust within the industry. A successful approach will involve a robust governance framework complemented by validated technologies, ensuring that PV teams remain integral to the process. By combining scalable AI with localized human expertise, companies can create streamlined operations that are both compliant and resilient.
Ultimately, the objective of pharmacovigilance is to protect patients. As technological advancements continue, the foundational 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 thrive in this evolving landscape.
About Ana Pedro Jesuíno: Ana Pedro Jesuíno serves as the Marketed Product Safety Associate Director at IQVIA, bringing over ten years of experience in pharmacovigilance across both contract research organizations and pharmaceutical industries. She oversees IQVIA’s Local QPPV Global Network and holds a master’s degree in Pharmaceutical Sciences.
