Pharmacovigilance failures tend to surface publicly only when something goes wrong. A delayed safety signal, an inspection finding or a post market correction can quickly escalate into reputational and financial consequences for drugmakers.
Against that backdrop, shifting regional expectations are forcing companies to reconsider how local pharmacovigilance responsibilities are defined, resourced and monitored, especially for products already on the market.
In the following Q&A, Ana Pedro Jesuino, marketed product safety director at IQVIA, discusses how companies are approaching local pharmacovigilance oversight amid changing regulatory and operational demands.
Ana Pedro Jesuino
Q: You’ve argued that Local Qualified Persons for Pharmacovigilance (LQPPVs) are shifting from a regulatory checkbox to a core business protection function. Can you give examples of concrete signals that support that argument?
A: As AI and generative AI continue to work their way into PV operations and workflows, regulators are scaling their expectations for transparency, validation, monitoring and human accountability. Simultaneously, these same regulators are strengthening their emphasis on continuous inspection readiness and robust vendor oversight. This modernized approach shifts pharmacovigilance from periodic compliance to an ongoing business resilience function, where any lapses can damage market trust and investor confidence.
Local QPPVs are no longer just a regulatory checkbox; they’ve become critical to business resilience. A clear example is crisis management: LQPPVs work in cross-functional teams to ensure rapid communication with authorities to avoid supply disruptions and reputational damage.
They also provide strategic input about market access. In the Middle East, early involvement by LQPPVs in pre-launch risk assessments has prevented costly delays by flagging country-specific PV requirements. In Europe, their insights on local safety trends have influenced reimbursement strategies for high-risk products.
On the tech side, LQPPVs now drive digital and data governance, validating AI-based PV tools to ensure compliance and data integrity. Finally, their organizational role has shifted. Many report directly to senior management and shape PV budgets. These changes show LQPPVs are not just compliance officers — they’re a safeguard for revenue and reputation.
Q: Can you point to examples where pharmacovigilance or LQPPV gaps translated into measurable business impact?
A: Compliance failures in pharmacovigilance can have far-reaching financial consequences. Missing QPPV oversight has led to multi-country launch suspensions, costing companies millions in lost revenue. Even minor submission delays can erode asset value. Industry analyses show that a one-month delay for a blockbuster drug can reduce net present value by tens of millions. Beyond launches, gaps in PV systems have triggered infringement actions, recalls and litigation, with recent impurity-related recalls alone estimated to cost the industry up to $45 billion. These disruptions ripple investor confidence, which raises the cost of capital and drives stock volatility. The message is clear: PV gaps aren’t just regulatory risks, they’re material business threats.
Q: From your perspective, what distinguishes a mature LQPPV function from one that is just barely compliant?
A: A mature LQPPV function demonstrates continuous inspection readiness, strong vendor oversight and embedded governance over both human-driven and AI-enabled workflows. They maintain audit trails, validation checkpoints and localized regulatory interpretation across markets. A barely compliant function relies on static, periodic processes that struggle to keep pace with AI-enabled data velocity and evolving regulatory expectations.
Q: Many companies struggle to find and retain qualified LQPPVs. What practical models are you seeing work in the field?
A: There are two models that offer a solution to finding and retaining LQPPVs. The first is the hybrid internal-external approach, which utilizes internal PV leadership in conjunction with external LQPPV support. The second approach focuses on strategic outsourcing, which is when organizations tap experienced, locally qualified professionals outside their organizations without investing valuable resources in every market. The benefit of both models is their ability to allow organizations to scale operations up or down as needed.
Q: You mentioned “continuous inspection readiness.” What does that look like in day-to-day operations for an LQPPV?
A: Continuous inspection readiness is a multi-layered proactive stance that organizations should begin to lean into. This means always maintaining audit-ready documentation, ongoing vendor oversight with defined escalation pathways, validated and monitored AI systems, and clear quality checkpoints for data accuracy. Instead of waiting for inspections and being reactionary, LQPPVs can operate with persistent oversight embedded into daily workflows.
Q: For organizations considering partnering with external LQPPV specialists, what criteria should they use to evaluate a vendor-neutral partner? Are there red flags?
A: When partnering with external LQPPV specialists, it is important to evaluate based on regulatory expertise, experience with AI-enabled PV systems, breadth of PV services and ability to support continuous compliance across jurisdictions. Conversely, several areas could raise concern when considering an external LQPPV. These include weak documentation practices, unclear escalation paths, a lack of AI validation governance and fragmented service delivery, which increases oversight burden.
Q: If you had to build a business case for strengthening LQPPV capabilities to a CFO, which metrics would you emphasize?
A: The business case that should be proposed to CFOs around strengthening LQPPV capabilities should focus on overall risk mitigation and business resilience rather than a specific KPI set. As stated earlier, organizations should focus on solidifying their proactive stance. This can be done by maintaining inspection readiness, regulatory alignment across markets, governance maturity for AI and automation, operational continuity during staffing or workload fluctuations and protection of market trust and investor confidence. When these considerations are accounted for, CFOs will be able to better understand the business case for LQPPVs as well as their returns on their investments.
Filed Under: Pharmacovigilance
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