Pharmacovigilance (PV) is experiencing a renaissance. Artificial Intelligence (AI) is no longer a futuristic concept in PV; it’s here, reshaping how we manage safety data, detect signals and maintain compliance. From automating case intake to accelerating literature screening and supporting aggregate reporting, AI promises efficiency and scalability at a time when data volumes and regulatory expectations are soaring. Yet, for all its potential, AI introduces a new challenge: trust.
Regulators around the world are raising expectations around transparency, accountability and oversight. These pressures are pushing PV teams to move beyond traditional compliance models and adopt more adaptive, technology-enabled frameworks. To succeed, this shift must balance innovation with responsibility to build a culture in which advanced technology enhances, rather than replaces, human judgment to safeguard patient safety.
AI’s promise meets regulatory reality
Regulatory bodies are intensifying their efforts to ensure that AI systems are not only effective but also adhere to standards of fairness, transparency and accountability. These principles translate into practical expectations: AI systems must be explainable, auditable and free from bias that could compromise patient safety or distort clinical decision-making. One example of this step in regulatory vigilance is the European Medicines Agency’s Good Pharmacovigilance Practices (GVP), which emphasizes the value of ongoing vendor oversight, escalation pathways and clear documentation. Similarly, the U.S. Food and Drug Administration (FDA) has reaffirmed that, while automation improves speed and scale, human oversight still remains indispensable. These shared values form the foundation for integrating AI into pharmacovigilance responsibly.
This duality of embracing innovation while also remaining compliant is reshaping PV operating models and pushing professionals to rethink structural operations. Organizations must prove not only that their systems work, but that the AI technology within them is validated, explainable and ethically supervised. As a result, continuous inspection readiness has become a standing requirement instead of a one-time milestone, demanding proactive governance and transparent processes at every step.
Data volumes vastly outpace manual capacity, calling for machine intelligence
PV professionals encounter numerous streams of information ranging from clinical trials to electronic health records, relevant medical literature and even social media content. Attempting to manually review this amount of information is not feasible. This is where machine learning can assist by screening reports, identifying hidden patterns and flagging anomalies with greater speed and consistency. However, while AI can help process large data sets, it still falls to PV professionals to provide their validation and interpretation of cultural nuances, clinical relevance and emotional tones.
An example of where human expertise shines would be when a patient states, “I got a stomachache” versus “I got a stomachache that derailed my day.” The latter suggests a higher impact on quality of life — something AI might miss without human oversight. As regulatory expectations evolve, PV teams must establish audit trails, quality checkpoints and documentation of their efforts. This ensures that automation enhances compliance instead of compromising it, delivering both efficiency and trust.
Local qualified persons for pharmacovigilance serve as anchors of local accountability
As the pharmaceutical landscape becomes more AI-enabled, local qualified persons for pharmacovigilance (LQPPVs) remain the critical bridge between global operations and local authorities. Rich in their knowledge of regional context, something that automation cannot replicate, LQPPVs can interpret national requirements, oversee vendors, monitor literature and ensure consistent inspection readiness. As global reach expands, pharmaceutical operations will face many challenges, particularly in terms of navigating complex regulatory environments, different reporting timelines, language nuances and cultural expectations. This is where LQPPVs become a unique solution to ensure that organizations remain compliant in each market by interpreting AI outputs within the context of local laws and cultural nuances. Their oversight ensures that the integration of AI does not compromise patient safety, regulatory trust or operational integrity.
Ongoing oversight as a differentiator
Compliance is no longer episodic — it must be continuous and proactive. As AI-driven processes and submissions become more common, organizations that demonstrate sustained oversight will be best positioned to navigate scrutiny from regulators. Local qualified persons for pharmacovigilance working closely with regulatory bodies and industry partners will drive the development of best practices for AI validation and ethical AI deployment. This collaboration between regulators and industry partners will define how AI should be ethically deployed within PV systems to ensure that patient safety and compliance are not compromised.
The future of pharmacovigilance and trust within the industry depends on the decisions that organizations make about today’s approaches. . The successful approach will be layered with a reliable and validated technology and a strong governance framework that keeps PV teams in the loop. By combining scalable AI with localized human expertise, companies can avoid the path of fragmentated processes and instead walk down one that is harmonized with global operations that are both compliant and resilient.
Pharmacovigilance ultimately exists to protect patients. As technology evolves, its guiding principles of safety, transparency and accountability will remain steadfast. The organizations that thrive will view AI not as a substitute for human vigilance but as its most powerful ally.
About Ana Pedro Jesuíno
Ana Pedro Jesuíno is the Marketed Product Safety Associate Director at IQVIA, with more than 10 years’ pharmacovigilance experience, including in both CRO and pharmaceutical industries. She has oversight of IQVIA’s Local QPPV Global Network and holds a master’s degree in Pharmaceutical Sciences.
