From Automation to Intelligence: How AI Is Changing the PV Scientist's Role
What you'll take away
- How AI capabilities go beyond traditional automation to support signal detection, case processing, and risk assessment
- The emerging skill set PV scientists need to stay effective as intelligent tools become standard
- Where human oversight and scientific judgment remain essential—and why
- Practical considerations for adopting AI responsibly within a compliant, validated PV framework
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Validating AI and ML in Clinical Systems: Extending CSA to GCP
Why now
Navigating the AI Shift: Decision Support and the Evolution of Pharmacovigilance
For years, automation has handled the repetitive backbone of pharmacovigilance—case intake, data entry, duplicate detection. But a new shift is underway. AI is moving beyond simple task automation into genuine decision support, and that's reshaping what it means to be a PV scientist. This panel brings together drug safety leaders and AI experts to explore how intelligent systems are changing day-to-day PV work, what new skills the role now demands, and how teams can adopt these tools without losing the human judgment that patient safety depends on.
Sponsored by
Join moderator Sai Darshana Jayakumar (One Vector) alongside panelists from Blueprint Medicines and One Vector for a practical conversation about where AI is adding real value in pharmacovigilance today—and where the scientist's expertise remains irreplaceable.
Built for
Who should attend.
Built for the people who have to validate, govern, and defend AI-enabled clinical systems.
Clinical Quality Assurance
GCP Compliance
GCP Auditors
Regulatory Affairs
Clinical Operations
Clinical Data Management
CSV / CSA
IT Quality
Clinical Systems
The panel
Who you'll hear from.
A panel of practitioners who live inside these questions, moderated live with audience Q&A.
Moderator
Tim Roy Kirkelie
Co-Founder & COO
Genari AI
Panelist
Munya Mafemba
Director, Digital Quality Assurance
Signant Health
Panelist
Amanda Forsythe
Head of Quality
Carelane
Panelist
Ankita Mishra
Digital Health Quality Director
Evinova
The series
Part of AI in Clinical Operations & Clinical Trials.
Six live panels on where artificial intelligence is reshaping clinical trials. Free to attend, and every session recorded.
3
Oct 27, 2026
6
Generative AI for Protocols, CSRs, and Regulatory Narratives
Jan 14, 2027
