From Automation to Intelligence: How AI Is Changing the PV Scientist’s Role
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
Save your seat
Free to attend. Can't join live? Register and we'll send the recording.
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
Sai Darshana Jayakumar
Director Pharmacovigilance Services
One Vector
Panelist
Sam Tamulevich
Director, Pharmacovigilance Scientist/Data Analytics
Blueprint Medicines
Panelist
Anand Ananthakrishnan
Senior Director, Drug Safety & Pharmacovigilance
Blueprint Medicine
Panelist
Amith Konanur
Chief AI Officer
One Vector
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
AI in GXP 2027 Outlook: Predictive Quality, Guardrails & Global Consistency
- Webinar
AI in GXP 2027 Outlook: Predictive Quality, Guardrails & Global Consistency
What emerging technologies and regulatory thinking signal for the year ahead
- December 9, 11:00 AM - 12:15 PM EST
Sponsored by:
AI in GXP 2027 Outlook: Predictive Quality, Guardrails & Global Consistency
What emerging technologies and regulatory thinking signal for the year ahead
December 9, 11AM – 12:15 PM EST
AI expectations will continue to accelerate in 2027 as organizations adopt predictive analytics, strengthen governance, and align with global regulatory expectations. This webcast explores what’s coming next for AI use across GxP systems, including early regulatory indicators, emerging technologies, and best practices for maintaining oversight and consistency.
What You’ll Learn:
- Early regulatory signals for 2027
- Predictive quality and advanced analytics
- Governance frameworks for responsible AI
- Data integrity considerations for algorithmic systems
- Documentation strategies supporting AI oversight
- Emerging risks in AI deployment
- Cross-functional collaboration models
- Technology trends shaping next year’s capabilities
Who Should Attend:
Quality leaders, IT and digital transformation teams, regulatory professionals, validation and data integrity specialists, and anyone planning to expand AI use in 2027.
-
December 9
11:00 AM - 12:15 PM EST
If you’re interested in this webinar – check out following event(s)
- Laboratory University Download Agenda
Pharma Engineering: Automation, Facilities & Process Excellence Trends
- Webinar
Pharma Engineering: Automation, Facilities & Process Excellence Trends
Advances in utilities, automation, and integrated process design shaping next-year readiness
- November 11, 11AM - 12:15 PM EST
Pharma Engineering: Automation, Facilities & Process Excellence Trends
Advances in utilities, automation, and integrated process design shaping next-year readiness
November 11, 11AM – 12:15 PM EST
Pharmaceutical engineering continues to advance as automation, facility modernization, and digital integration shape next-generation operations. This webcast highlights the trends that will most influence engineering programs heading into 2027, including utility upgrades, automation strategies, and data-driven performance monitoring. Learn how organizations are preparing for more resilient and efficient facility operations.
What You’ll Learn:
- Key facility and automation trends for 2027
- Integration of digital tools into engineering operations
- Utility and HVAC improvements influencing compliance
- Process optimization and modernization strategies
- Engineering documentation for hybrid environments
- Data-driven monitoring and performance insights
- Collaboration models between engineering and quality
- Common engineering audit observations
Who Should Attend:
Engineering leaders, automation specialists, facility managers, process engineers, CQV teams, and manufacturing/operations professionals.
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November 11
11AM - 12:15 PM EST
If you’re interested in this webinar – check out following event(s)
- Validation University 2026 Download Agenda
- Pharmaceutical Engineering Summit 2026 Download Agenda
- CSV & CSA University Europe 2026 Download Agenda
Building High-Quality Validation Documentation: Protocols, Reports, and Evidence That Stand Up to Scrutiny
- Webinar
Building High-Quality Validation Documentation: Protocols, Reports, and Evidence That Stand Up to Scrutiny
Techniques for improving documentation clarity and consistency across traditional, digital, and AI-supported validation approaches
- January 20, 11AM - 12:15 PM EST
Building High-Quality Validation Documentation: Protocols, Reports, and Evidence That Stand Up to Scrutiny
Techniques for improving documentation clarity and consistency across traditional, digital, and AI-supported validation approaches
January 20, 11AM – 12:15 PM EST
Strong validation documentation remains essential for demonstrating system control, traceability, and compliance. This webcast focuses on practical methods for improving the quality of protocols, test scripts, and reports across diverse system types, from legacy to cloud to AI-supported environments. Learn how to simplify content, strengthen justification, and ensure documentation accurately reflects validation activities throughout the lifecycle.
What You’ll Learn:
- Common documentation gaps and how to correct them
- How to write clearer, more defensible protocols and test scripts
- Best practices for integrating digital and cloud system evidence
- How AI-supported tools influence documentation structure and content
- Approaches for improving traceability and rationale within reports
- Templates and formatting techniques that reduce confusion and redundancy
- Strategies for aligning QA, system owners, and validation teams
- Methods for maintaining consistency across multi-system environments
Who Should Attend:
Validation professionals, QA reviewers, documentation specialists, IT system owners, compliance leads, and anyone responsible for writing, reviewing, or approving validation deliverables.
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January 20
11AM - 12:15 PM EST
If you’re interested in this webinar – check out following event(s)
- CSV & CSA University Download Agenda
Validating Cloud and Hybrid GxP Systems
- Webinar
Validating Cloud and Hybrid GxP Systems
Supplier Assessment, Change Control, and Vendor-Deployed AI
- October 14, 11AM - 12:15 PM EST
Validating Cloud and Hybrid GxP Systems
Supplier Assessment, Change Control, and Vendor-Deployed AI
October 14, 11AM – 12:15 PM EST
Most GxP environments are now hybrid whether anyone planned it or not. Legacy on-premise systems sit alongside SaaS platforms that update on the vendor’s schedule, not yours, and the validation package written at implementation assumed a system that would hold still. It hasn’t. Meanwhile suppliers are shipping AI features into validated systems as routine releases, and most quality organizations have no mechanism to catch it, assess it, or document a decision about it. This session covers how to validate systems you do not control: what to demand from supplier assessment and how far you can lean on vendor testing under CSA, how to build change control that survives a quarterly release cadence, and what to do when a feature you did not ask for lands inside a validated application.
What You'll Gain:
- Understand where supplier qualification ends and your validation obligation begins in a shared responsibility model
- Learn how to leverage supplier testing evidence under a risk-based CSA approach, and where regulators expect you to test anyway
- See how to design change control and periodic review around vendor release cycles rather than against them
- Discover how to assess and document vendor-deployed AI features introduced into validated systems
- Gain insight into what GAMP 5 Second Edition asks for in cloud and hybrid environments, applied rather than summarized
- Hear how organizations are handling this in practice, including what has failed
Who Should Attend:
- CSV, CSA, and computerized systems validation professionals
- Quality assurance and IT compliance leads
- System owners and business process owners for cloud-based GxP applications
- Supplier qualification and vendor management professionals
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October 14,
11AM - 12:15 PM EST
If you’re interested in this webinar – check out following event(s)
- CSV & CSA University Download Agenda
