AI-enabled patient engagement is changing how safety information enters pharmaceutical organizations. Safety information that once arrived through structured forms or tightly controlled channels are now embedded in chat interactions, digital support tools, and other high-volume touchpoints.
For pharmacovigilance (PV) teams, this shift raises practical and strategic questions:
- How is safety oversight maintained when information is unstructured and ambiguous?
- How can companies ensure thorough review of this possible source of safety information?
- How can new engagement models be supported to ensure regulatory compliance?
In a recent webinar hosted by Botco AI, Two Speeds, One Mission: Syncing AI Patient Engagement with PV Compliance Confirmation, Olga Minkov, Senior Director Medical Operations at SSI Strategy, discussed how PV accountability remains constant as AI-enabled patient engagement expands across the organization, and why early PV involvement is critical to managing compliance risk. The discussion examined how organizations are rethinking PV oversight through risk-based operating models that can adapt to AI-enabled patient engagement.
Topics addressed
- How PV accountability is maintained as engagement capabilities scale across functions and platforms
- How ambiguity and volume in digital patient interactions change traditional safety intake and review assumptions
- How risk-based operating models support different levels of oversight and human review based on the impact and autonomy of AI-enabled workflows
- How recent regulatory guidance and inspection activity inform expectations for governance, validation, and ongoing monitoring
The webinar provides a detailed discussion of how PV teams are reassessing oversight and governance models to remain inspection-ready while supporting evolving engagement strategies.
