AI in Pharmacovigilance and Managing Change: Insights from our whitepaper

As AI in pharmacovigilance gains momentum, organizations are recognizing not just the transformative potential of the technology, but also the complexity of managing its adoption. From signal detection pharmacovigilance to optimizing drug safety pharmacovigilance processes, AI promises accelerated efficiency and proactive benefit-risk management. Yet, the real challenge lies in aligning the people and processes to realize these benefits sustainably, a task where organizational change management consultants play a critical role in guiding strategy and mitigating resistance to ensure long-term success.

Our newly released white paper, “The Human Response to Artificial Intelligence: A Framework to Understand and Accelerate AI Adoption in Pharmacovigilance”, explores this intersection of people and technology and the need for organizational change management. Based on data from pvnet^®, executive interviews, and years of pharmacovigilance consulting, the paper offers actionable insights into AI adoption archetypes, managing workforce transition, and sustaining institutional knowledge.

How This White Paper Helps Companies Understand and Accelerate AI Adoption in Pharmacovigilance

1. A Human-Centered Framework for AI in Pharmacovigilance

While much of the industry discourse on artificial intelligence in pharmacovigilance revolves around technology, like use cases, tools, algorithms; this white paper shifts focus to the human response. Drawing from decades of change management research, particularly Everett Rogers’ Diffusion of Innovation Theory, the framework categorizes employees into five archetypes: Innovators, Early Adopters, Early Majority, Late Majority, and Laggards.

This model enables leaders to:

• Diagnose current employee attitudes toward AI in pharmacovigilance
• Predict likely friction points during rollout
• Design change interventions tailored to specific behavioral profiles

This is critical because successful AI deployment hinges on cultural and operational alignment across all stakeholders, from PV operations to compliance teams.

2. Incorporates Benchmarking Data from Industry Leaders

Leveraging insights from pvnet^® Navitas Life Sciences’ industry-leading global peer-to-peer network for leaders of top 25 life sciences companies.

Some highlights:

• Over 75% of companies are exploring the use of AIto ICSR receipt, triage, and data entry
• Signal detection pharmacovigilance is another key focus area, with 64% evaluating AI applicationsto review individual cases and scan external databases
• Fewer than 25% of companies are currently considering AI for narrative authoring and quality review, suggesting areas of hesitation or greater implementation complexity

These findings provide a realistic picture of AI maturity across the PV function and help organizations identify gaps in their own strategies.

3. Strategies for Managing Workforce Disruption and Knowledge Loss

One of the most overlooked consequences of AI in pharmacovigilance is staff turnover and institutional memory loss. As automation reshapes roles, employees, especially Laggards, may opt for early retirement or exit, fearing redundancy.

The white paper highlights the importance of proactively addressing these challenges through:

• Succession planning strategies to ensure continuity of critical safety expertise
• Methods to engage HR proactively in knowledge documentation and retention
• Approaches to upskilling and realigning pharmacovigilance specialists for higher-value roles
• Leveraging organizational change management services to support smooth transitions and workforce alignment

This is a crucial resource for any organization aiming to maintain compliance with good pharmacovigilance practice (GVP) during transition.

4. Operationalizes AI Change Management

The paper goes beyond theory to provide actionable guidance on building AI-readiness programs:

• How to create an “AI Advisory Group” to safely channel innovator enthusiasm
• How to structure organizational messaging to mitigate fear among laggards
• Techniques for minimizing “change fatigue” among early and late majority staff

This practical toolkit is a roadmap for pharmacovigilance solutions teams to integrate AI with minimal disruption and high adoption.

5. Bridges the Gap Between Tech and Business Strategy

Many organizations fall into the trap of viewing AI in pharmacovigilance as a standalone IT initiative.

This white paper reframes AI adoption as a business transformation effort that:

• Requires governance, SOP redesign, and training
• Must align with safety objectives like early signal detection and benefit-risk management
• Should be integrated across platforms (case processing, signal management, aggregate reporting)

By embedding AI strategy within the broader PV and business roadmap, companies can ensure alignment with regulatory expectations and enterprise goals.

6. Backed by Consulting Expertise and Peer Insights

What sets this paper apart is the credibility of its authors:

Latika and Casey bring decades of consulting, network benchmarking, and operational experience in drug safety pharmacovigilance, offering insights grounded in both strategic foresight and hands-on implementation.

Why It Matters Now

As regulatory bodies begin exploring AI frameworks (e.g., FDA’s recent discussion papers on AI in drug development), sponsors and CROs alike must ensure that their use of artificial intelligence in pharmacovigilance is:

• Transparent and auditable
• Clinically and operationally validated
• Aligned with existing GVP and safety surveillance norms

Take the Transformative step towards AI in Pharmacovigilance with Navitas

Whether you're piloting AI tools or building a full transformation roadmap, Navitas Life Sciences can help. Our expertise in pharmacovigilance solutions, global change management, and network-driven insights makes us the ideal partner in your journey.

Contact us at This email address is being protected from spambots. You need JavaScript enabled to view it. or visit www.navitaslifesciences.com to learn how we can help you adopt AI confidently and collaboratively.