Pharmacovigilance (PV) is undergoing a fundamental shift. Regulators are increasing their expectations for artificial intelligence’s credibility, explainability and validation. Simultaneously, data volumes continue to accelerate, and AI is becoming deeply embedded in safety operations. To match the pace of innovation, the U.S. Food and Drug Administration issued guidance on AI in drug development, outlining expectations for model transparency, monitoring and human accountability. 

Once seen as a technical compliance function, PV is now a core component of business resilience. Any lapses in compliance carry long-term consequences, such as loss of market trust and investor confidence and damage to organizational reputation. In this environment, local qualified persons for pharmacovigilance (LQPPVs) emerge as anchors of oversight. Their task is to ensure that PV systems remain accountable, transparent and aligned with evolving regional requirements.

The expanding role of LQPPVs

The role of LQPPVs has become increasingly critical as PV systems continue to integrate more advanced technologies. They act as a bridge between global safety operations and the unique regulatory environments of each country or region. With responsibilities extending far beyond documentation requirements, LQPPVs ensure that PV systems remain in compliance with national expectations, interpret local laws and maintain inspection readiness across diverse jurisdictions.

However, the traditional PV model — built on static processes and periodic reporting — cannot keep pace with the velocity of global safety data and AI-driven workflows. Compliance frameworks designed for yesterday’s environment risk creating blind spots in today’s dynamic landscape. Organizations need adaptive, continuously data-driven systems with LQPPVs acting as strategic nodes validating AI outputs, monitoring local compliance in real time and leveraging predictive analytics to anticipate risks before they materialize.

Another area where LQPPVs can provide essential oversight is through the application of AI within PV workflows. These professionals can assess whether outputs are consistent with local regulatory standards, evaluate emerging safety information in context and validate ongoing automated processes. Technology alone cannot offer such a localized approach. LQPPVs are rooted in cultural awareness, language familiarity and an understanding of national reporting norms. Without them, the elements fundamental to the credibility of pharmacovigilance systems would otherwise go missing or remain incomplete.

Organizations without LQPPVs risk introducing inconsistencies across markets, fragmenting complex workflows and creating unnecessary regulatory exposure. By providing a continuous loop of oversight, LQPPVs can maintain accountability during changes in organizations or operations, as well as during gaps in staffing. 

Why LQPPV partnerships strengthen business resilience

According to a 2024 report by McKinsey, generative AI could generate between $60 billion and $110 billion in annual value for the pharmaceutical industry. However, realizing this potential requires more than technology alone; it demands robust governance frameworks and prioritization of human oversight. A leading business model has internal expertise along with LQPPV support to create a scalable adaptive PV ecosystem that balances efficiency with accountability. This reflects a broader industry trend toward continuously data-driven systems that integrate automation without compromising compliance or trust. LQPPVs deliver measurable impact in several critical areas:  

• Regulatory alignment: LQPPVs ensure adherence to country-specific requirements, maintain documentation standards and support ongoing inspection readiness.
• Governance maturity: Organizations can show responsible use of automation to regulatory bodies by showcasing how they leverage human expertise over AI-powered processes.
• Operational continuity: LQPPVs provide an additional layer of flexible support that enables organizations to scale resources during shifts in staffing or during workload surges.
• Global consistency: Localized expertise helps organizations navigate differing regional processes and avoid fragmenting PV workflows.

LQPPVs have evolved beyond regulatory assets — they are strategic partners enabling organizations to build resilient, future-ready PV systems.

Building trust in an AI-enabled PV environment

A central theme that defines PV modernization is the establishment of comprehensive and robust trust. Organizations must seek out the trust of regulators and end users that their systems are not only effective but are also governed responsibly. Achieving this requires rigorous model validation, transparent decision-making and continuous monitoring to ensure alignment with evolving regulatory expectations. LQPPVs reinforce this trust by providing consistent oversight across both human-driven and AI-enabled workflows. They stand ready to help teams navigate regulatory changes, guide the interpretation of nuanced safety data and maintain inspection readiness. LQPPVs are critical components for ensuring that AI does not compromise the credibility, accuracy or compliance of PV systems.

Human expertise remains foundational

Traditional PV operations relied on labor-intensive manual processes. Today’s advances in AI and machine learning have replaced these time-consuming tasks. Teams can build unique AI and machine learning models to screen vast amounts of reports, identify obscure patterns within data and reduce manual burdens. 

However, the integration of AI into safety procedures should not completely replace human judgment. While automation improves speed and scalability, a recent analysis of AI in PV emphasizes that experts still see human oversight as the gold standard when evaluating contextual nuances, validating outputs and ensuring responsible use of technology.  

AI cannot fully differentiate between subtle expressions of patient experiences, cultural nuances in reporting or differences in emotional tone embedded within adverse event narratives. These interpretations should remain the responsibility of qualified PV professionals.

Global regulators are looking to organizations for a carefully balanced approach, one that acknowledges efficiency through automation in conjunction with expert oversight. This approach recognizes the reality that PV systems must be both technologically enabled and grounded in human accountability.

A path toward resilient and future-ready PV systems

Today’s PV professionals face growing pressure driven by evolving regulations, increasing data complexity and heightened expectations around AI governance. Leveraging LQPPVs alongside advanced technologies will be essential. LQPPVs offer the contextual grounding, nuance and oversight required to ensure that PV processes remain compliant, resilient and adaptable. By integrating LQPPVs into governance models, companies can safeguard compliance, protect reputation and unlock the full potential of AI — transforming PV into a strategic pillar of business resilience. 

Ana Pedro Jesuíno is the Marketed Product Safety 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.