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Session 5: Fit-for-Purpose Pharmacovigilance: Real-World Best Practices and Strategic PV Planning for Small and Emerging Companies
Session Chair(s)
Barbara Hendrickson, DrMed, MD
Clinical Associate, Pediatric Infectious Diseases
University of Chicago, United States
Bethany Van Veen
CEO and Founder
Perspective Pharmacovigilance, United States
Small and mid-size biopharma companies face unique pharmacovigilance challenges—balancing lean resourcing with complex regulatory expectations. This session highlights the importance of embedding strategic safety planning and benefit–risk thinking early in clinical development, ensuring PV is seen as a value driver rather than a cost center. Panelists will explore how early company oversight of vendors and strong operational foundations help prevent compliance gaps, while systematic safety planning leads to better outcomes. Through real-world case studies, panelists will illustrate the downstream consequences of insufficient PV planning and share examples of how proactive frameworks can prevent such outcomes. Attendees will leave with actionable tools to build scalable safety infrastructure, strengthen cross-functional credibility, and position PV as a driver of long-term program success.
Learning Objective : - Demonstrate strategies to position PV as a value driver
- Discuss benefits of early, systematic safety planning
- Analyze real-world case studies where inadequate PV planning caused regulatory delays, restrictive labels, or significant inspection findings
- Implement a “first 100 days” framework for new PV leaders
- Outline approaches for cross-functional alignment to elevate PV’s influence and recognition within the organization
Speaker(s)
Speaker
Sarah Chesler, BSN
Beam Therapeutics , United States
Vice President, Pharmacovigilance
Speaker
Renee Breed
Independent Consultant, United States
Pharmacovigilance
Speaker
Famina Hemani
Tourmaline Bio, United States
Vice President, Head of Pharmacovigilance
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