As artificial intelligence continues to reshape pharmacovigilance, the role of the local qualified person for pharmacovigilance (LQPPV) is evolving but not disappearing. While AI offers powerful tools for automation, signal detection, and global surveillance, it cannot replace the human judgment, regulatory expertise, and emotional intelligence that LQPPVs bring to drug safety monitoring.

The evolving role of the local QPPV

Historically, the local QPPV served as the primary point of contact between pharmaceutical companies and regulatory authorities, ensuring oversight of product safety. Today, that role has expanded significantly. LQPPVs are now expected to:

• Act as internal educators on pharmacovigilance practices.
• Communicate effectively across departments and with regulators.
• Understand and evaluate the integration of AI into PV systems.
• Ensure that AI tools meet compliance standards and regulatory expectations.

This shift requires a broader skill set, including technological fluency and strategic thinking. LQPPVs must be open to innovation while remaining vigilant about maintaining compliance.

Where AI fits into pharmacovigilance workflows

AI is already enhancing pharmacovigilance by automating tasks such as:

• Machine translation and natural language processing for case handling.
• Signal detection across large, noisy datasets.
• Literature surveillance and duplicate detection.
• Narrative generation and coding.

These capabilities allow PV teams to process vast amounts of data quickly and accurately. For LQPPVs, the challenge is to ensure that these tools are implemented in a way that aligns with regulatory standards and preserves the integrity of safety monitoring.

What AI still lacks

Despite its strengths, AI cannot replicate the human component of pharmacovigilance. One critical gap is emotional intelligence. When patients report adverse events, their emotional tone can provide important context. AI tools are not yet capable of interpreting these nuances, which means human oversight remains essential.

Other limitations include:

• Data privacy concerns in highly regulated environments.
• The need for validated, transparent systems.
• Real-time updates and algorithmic clarity.

LQPPVs must work closely with AI developers to address these challenges and ensure that tools are trustworthy and compliant.

Navigating global regulatory complexity

The global nature of pharmacovigilance adds another layer of complexity. Different countries have different regulatory frameworks for AI, making it difficult for professionals to stay current. In the EU, for example, regulations emphasize ethics and explainability, while other regions may prioritize innovation or scalability.

To manage this complexity, collaboration is key. LQPPVs, regulators, marketing authorization holders, and technology providers must work together to:

• Share insights and best practices.
• Develop tools that meet diverse regulatory requirements.
• Create harmonized frameworks that support global compliance.

As AI becomes increasingly integrated into pharmacovigilance, the need for tools that are both powerful and compliant with global regulations has never been more critical. IQVIA recognizes that this balance can only be achieved through collaboration across the pharmaceutical ecosystem.

Extending AI to underdeveloped regions

AI also holds promise for improving pharmacovigilance in underdeveloped countries. While access to electronic health records and structured reporting may be limited, AI can help by:

• Extracting data from handwritten notes and local languages.
• Supporting mobile health apps and offline systems.
• Adapting to regional dialects and cultural nuances.

These innovations can expand the reach of drug safety monitoring and support more equitable healthcare outcomes worldwide.

The future of LQPPV in an AI-enabled world

As AI becomes more integrated into pharmacovigilance, the role of the LQPPV will continue to evolve. Rather than being replaced, LQPPVs will become strategic stewards of AI tools, guiding their implementation and ensuring that safety monitoring remains accurate, ethical, and compliant.

Key responsibilities will include:

• Oversight of AI performance and validation.
• Interpretation of complex safety signals.
• Cross-functional collaboration and education.
• Advocacy for patient safety across global markets.

In this new landscape, LQPPVs are not just adapting—they are leading. Their expertise, judgment, and commitment to compliance make them indispensable in the future of drug safety monitoring.