AI Governance in Pharmacovigilance

AI is entering pharmacovigilance. The critical question is no longer whether organisations will use it, but whether they can govern it responsibly.

Artificial intelligence can improve efficiency, support signal detection, accelerate case processing, and strengthen access to safety information. It can also introduce new risks involving unreliable outputs, automation bias, data quality, privacy, model drift, weak human oversight, and unclear accountability.

AI Governance in Pharmacovigilance provides a practical framework for managing these risks across the complete AI system lifecycle. It connects emerging AI requirements with established pharmacovigilance, quality, and patient-safety responsibilities.
Drawing on global regulatory developments, recognized standards, and more than 24 years of pharmacovigilance experience, Julia Appelskog explains how organisations can move from broad ethical principles to governance controls that work in practice.

This book will help you:

• Evaluate and classify AI use cases according to risk
• Establish clear roles, responsibilities, and decision-making authority
• Design meaningful human oversight and reduce automation bias
• Govern data quality, privacy, fairness, and traceability
• Validate AI-enabled systems for their intended purpose
• Manage vendors, third-party models, and contractual responsibilities
• Monitor performance, errors, drift, changes, and emerging risks
• Investigate incidents and control system decommissioning
• Prepare documentation and evidence for quality review, audit, and inspection
• Align AI governance with the EU AI Act, pharmacovigilance requirements, and international expectations

The book also examines issues that are often overlooked, including the cognitive risks of AI, anthropomorphic language, explainability theatre, environmental impact, organisational readiness and the challenge of maintaining human expertise as automation expands.

Written for:

• QPPVs and pharmacovigilance leaders
• Drug-safety and regulatory professionals
• Quality, compliance, and audit teams
• AI governance and data governance specialists
• Validation, technology, and information-security professionals
• Pharmaceutical executives responsible for AI adoption
• Consultants, researchers, and students working at the intersection of AI and medicines

AI Governance in Pharmacovigilance offers a structured approach to using AI while protecting scientific judgment, regulatory compliance, and patient safety.