Special Episode | Recording with The Top Line: AI is changing drug safety, but governance sets the guardrails

Jan 15, 2026

Marie Flanagan, Regulatory and AI governance lead at IQVIA Safety Technologies with ~20 years in pharmacovigilance, talks about aligning AI with regulatory frameworks. She covers shared responsibility across teams. She explains platform-level governance and seven guiding principles. She highlights continuous monitoring, human-in-loop design, bias detection, and baking guardrails into system design.

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ANECDOTE

Two Decades In Pharmacovigilance

Marie Flanagan has 20 years in pharmacovigilance and recently moved into AI governance at IQVIA Safety Technologies.
Her background spans operations, strategy, consulting, and now regulatory and AI governance work.

INSIGHT

Shared Responsibility For AI In Safety

AI responsibility in pharmacovigilance is shared across process owners, multidisciplinary oversight boards, and regulators.
Marie Flanagan emphasizes that regulators like the EMA and FDA play a critical external governance role.

INSIGHT

Platform-Level Governance Protects End-To-End

Platform-level governance covers strategic, technical and operational oversight across the entire ecosystem rather than a single model.
Without it, AI tools risk siloed outputs, accountability gaps, and unvalidated safety decisions.

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Artificial Intelligence (AI) is no longer a futuristic concept in life sciences—it’s here, transforming drug safety and pharmacovigilance at an unprecedented pace. But as the industry embraces automation and advanced analytics, one truth stands firm: innovation without governance is a risk no one can afford.
In this episode of The Top Line, we explore how AI is reshaping drug safety while governance sets the guardrails for ethical, compliant, and sustainable adoption. Our featured guest, Marie Flanagan, Regulatory and AI Governance Lead at IQVIA Safety Technologies, dives deep into why governance isn’t just a checkbox—it’s the backbone of responsible AI deployment in healthcare.
Key Themes You’ll Discover:

The Dual Imperative: Innovation and Oversight
AI promises speed, accuracy, and scalability in pharmacovigilance, from case intake to signal detection. Yet, without robust governance frameworks, these benefits can quickly turn into liabilities. Learn why embedding governance into AI design from day one is critical—and why retrofitting controls later is a recipe for risk.

Shared Responsibility Across Stakeholders
Governance isn’t the job of one team. Flanagan explains how compliance, technology, business units, and regulators must collaborate to ensure AI systems are ethically designed, technically validated, and transparent. Discover how this multi-layered approach builds trust and resilience in a rapidly evolving regulatory landscape.

Principles That Matter: Human Oversight, Fairness, Accountability
From mitigating bias to ensuring explainability, guiding principles are more than buzzwords—they’re operational necessities. We unpack how these principles translate into practical steps, including continuous monitoring, feedback loops, and adaptive controls that evolve with technology.

Compliance as an Enabler, Not a Barrier
Traditionally seen as a brake on innovation, compliance teams can become catalysts for safe progress. Hear how organizations are reframing compliance roles to support innovation while safeguarding patient safety and regulatory integrity.

Global Regulatory Context
With frameworks like the EU AI Act and U.S. federal memoranda shaping expectations, companies must navigate a complex web of international standards. Flanagan shares insights on harmonizing governance strategies across jurisdictions without slowing down innovation.

Practical Playbook for Life Sciences
From zero-touch case processing to agentic AI in signal workflows, we spotlight real-world use cases that demonstrate how governance and technology can coexist—and thrive. Learn how IQVIA’s Vigilance Platform integrates governance into every layer of AI-driven pharmacovigilance.

Why This Matters Now
AI adoption in pharma is accelerating, with 85% of top companies prioritizing AI as a strategic imperative. But speed without structure can lead to compliance gaps, reputational damage, and patient risk. This episode equips you with the insights to innovate responsibly, ensuring your AI journey is both ambitious and anchored in governance.

Tune in for actionable strategies, expert perspectives, and a candid conversation on the future of drug safety in the AI era. Whether you’re a regulatory leader, technology strategist, or business decision-maker, this episode will help you balance the promise of AI with the principles that protect patients and preserve trust.