Artificial Intelligence in Pharmacovigilance: Applications in Case Processing

Linda Härmark, PharmD, MEpi, PhD, MBA

Dr. Linda Härmark has over 20 years of experience in pharmacovigilance, spanning research, strategic leadership, and international collaboration. She began her career at the Netherlands Pharmacovigilance Centre Lareb, where she held senior roles including Head of Innovation and Deputy Director. Currently, she is Director of the Drug Safety Research Unit, leading studies on medicine and vaccine safety using real-world data

She is passionate about patient involvement in pharmacovigilance, where she has conducted research and contributed to CIOMS XI’s report on patient involvement. She is committed to advancing pharmacovigilance in LMICs, having coordinated the WHO Collaborating Centre for Patient reporting and Education in PV and served on the executive board of the EDCTP-funded PAVIA project.

Linda has (co-)authored over 50 peer-reviewed publications. She serves on the steering committee of the European Chapter of ISoP bringing scientific depth and strategic insight to the evolving field of drug safety.

Karthick is a seasoned PV tech professional and transformative thought leader with over two decades of experience driving innovation in Pharmacovigilance.

Starting his career in 2003 as part of the grassroots team developing a custom Safety Database for a Top 5 Pharma, Karthick brings a deeply rooted, unique blend of insights from Industry, Consulting, Product Development, and Services.

In his current role at Roche, Karthick leads the Safety automation strategy and acts as the Business Lead for automation projects. As a technology evangelist, his recent trailblazing work focuses on leveraging AI for Agentic ICSR processing designing the new hybrid (Human+AI) operating model and pioneering the framework to safely govern autonomous workflows for PV.

Claudia Schaffer is Senior Director and Head of ICSR Management within Global Patient Safety at Merck Healthcare KGaA. She holds end-to-end accountability for ICSR management across all Merck compounds, leading a global team of approximately 80 professionals.

Her career spans nearly two decades in pharmacovigilance. Claudia is passionate about operational excellence and the responsible adoption of AI in drug safety.

At Merck, she is leading Project SPEED, the programme driving GenAI integration into ICSR case processing, and is a member of the GPS Leadership Team.

Niklas Norén is Chief Science Officer at the Uppsala Monitoring Centre, the WHO Collaborating Centre for International Drug Monitoring, and a member of its executive management team since 2009. He has published extensively on artificial intelligence in observational medical data, primarily adverse event reports and electronic medical records.

His research has resulted in scientific papers on duplicate detection and subgroup discovery that have been internationally awarded. He is a member of the editorial board for Drug Safety, and he has led several international collaborative projects in pharmacovigilance including the signal detection work-package in IMI PROTECT; the work-packages on detecting substandard medicines and drug dependence in Monitoring Medicines; and the social media analytics work-package in IMI WEB-RADR. He is a member of the CIOMS XIV working group on Artificial Intelligence in Pharmacovigilance.

Niklas holds a PhD in Mathematical Statistics from Stockholm University in 2007 and a MSc in Engineering Physics from Chalmers University of Technology in 2002.