Author: Claudia Schaffer, Head of ICSR Management at Merck KGaA, based in Darmstadt, Germany.

When we last convened at ArisGlobal Breakthrough in the spring of 2025, it was early days for NavaX in pharmacovigilance, with just a handful of small use cases being tested. Beyond a general acceptance of the technical feasibility of using AI to transform case intake and processing, most of us still needed to get into a position to be truly ready to harness the potential.

A year on, many of us have applications in production, or soon will have – so this is an exciting point to be meeting again. As thoughts turn to what AI use could mean for our operations and our people, we are bedding in NavaX’s capabilities more fully. I, for one, will be very interested to hear where other companies are now.

All of this will feed into the panel discussion, NavaX in Action: AI in Pharmacovigilance Case Intake & Processing, on February 10th. I’ll be taking part, along with my counterparts at BMS, Astellas, and J&J. We’ll be recounting our experiences to date, sharing our aspirations and planning next steps, as well as answering any questions raised.

Reviewing Team Roles in the Light of AI

The timing of the latest Breakthrough, beginning in early February, is ideal – giving us all the chance to build any takeaways into our roadmaps for 2026 and beyond.

As classical operational activities are handled increasingly by NavaX, there is a clear opportunity to adapt and elevate the role of specialists who have traditionally done this work. Those previously responsible for data entry, for instance, will have more time to review data extraction.

As we move closer to a light-touch workflow, the opportunities to use people’s skills in more constructive and interesting ways will grow considerably. This isn’t an all-or-nothing situation; rather, there is an opportunity to adapt from having five to six humans in the loop to one or two—or perhaps three for more complex cases, or where multiple languages are involved.

The panel will also look at the “NavaX effect” on downstream processes. As teams are able to handle more cases with fewer clicks, and as their role becomes more focused on verification, greater thought will need to be given to employee training and knowledge management.

Roles previously concentrated on data entry work could now be expanded to:

• Triage
• Quality review
• Medical assessment

This, in turn, implies greater ownership for those working with cases, which will need to be reflected in job titles, job descriptions, and skills development.

Extending NavaX’s Impact

Thought also needs to be given to how we manage case information recorded in other languages. I’ll be very interested to learn how others are tackling this challenge in order to leverage NavaX to its maximum potential.

I am also curious about how other companies are approaching operational evolution. It is one thing to streamline case processing, but unless we revise our processes, we won’t exploit AI’s fuller benefits. The more fundamental work needed now is around organizational change.

At Merck, we’re navigating this journey with our teams. We need to engage both experts and users and cultivate change ambassadors. We also want to avoid being too disruptive initially—it’s important to take people along on the journey, gain experience, prove that technology works, and address any fears they may have about their future roles.

At the time of writing, we are about four weeks into our implementation of NavaX for PV, but we have deferred any major process changes until later in 2026. Maintaining quality is just as vital as creating a lean and efficient process.

On an ongoing basis, we’ll work closely with the team to support these changes and address any anxiety. Our view is that NavaX’s AI functionality will make people more productive, while taking on the less enjoyable aspects of the work—such as wading through 50-page source documents.

Looking Ahead to Breakthrough 2026

I am greatly looking forward to Breakthrough 2026. The event is always inspiring and invaluable from both a networking and benchmarking perspective. I hope to see you there.

About the Author
Claudia Schaffer is Head of ICSR Management at Merck KGaA, based in Darmstadt, Germany.

Breakthrough 2026 Panel Session

On Day 1  at Breakthrough 2026, Claudia will take part in the panel session:

NavaX in Action: AI in Pharmacovigilance Case Intake & Processing

Moderator: Jason Bryant, ArisGlobal

Panelists:

• Claudia Lehmann, Head of Global Pharmacovigilance Operations, Boehringer Ingelheim
• Ellen Mishalov, Executive Director, Head of PV Transformation and Technology, Astellas
• Julie Thomas, Vice President, Global Medical Safety Operations, Johnson & Johnson
• Sam Wallis, Head of Case Management, Patient Safety, Bristol Myers Squibb