Henry Seto

EXPERTISE

Dr. Henry Seto's Expertise

Every engagement is different. Whether you're navigating a complex signal, building a safety function from scratch, or facing an inspection, I bring both clinical judgement and decades of executive experience to help you make the right call, not just the compliant one.

PV System Strategy & Oversight

I help you build or strengthen global safety frameworks that are compliant, scalable, and designed to work day-to-day, not just on paper. Whether you're starting from scratch or fixing what's broken, I'll make sure your PV system is built for where your organization is headed, not just where it is today.

Medical Safety Leadership

I've built global PV departments from the ground up, from 9 people and no marketed products to over 100 staff across 50 countries. I provide the senior medical leadership and strategic direction your organization needs, on demand and without the cost of a full-time executive hire.

Inspection & Audit Readiness

With experience across FDA, MHRA, and global affiliate offices, I help you identify and close compliance gaps before regulators ever walk through the door. No last-minute scrambles, no critical findings, just a system that holds up when it counts.

Signal Evaluation & Risk Management

I led one of the first large-scale industry business process outsourcing programs of its kind. I know what good vendor performance actually looks like, and I'll help you make sure your partners are delivering real quality, accountability, and value, not just meeting the contractual minimum.

Vendor & FSP Optimization

GVP & GCP Regulatory Compliance

I've spent decades working across FDA, EMA, and global regulatory frameworks, and I know where the gaps tend to appear. I help you build processes and documentation that don't just meet the current requirements, they hold up as regulations evolve and your portfolio grows.

LET'S TALK

Put Your Question to a Pharmacovigilance Expert

Tell us what you're working on, whatever the stage or market. We'll make sure your question reaches the specialist who leads that area, and that you get a real, considered answer back, not a brochure.

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Does It Really Matter if My PV Vendor Is Physician-Led?

Before you compare vendors or talk about outsourcing, you need to understand what great pharmacovigilance leadership really looks like. Dr. Henry Seto answers the question directly, and honestly. Press play to hear what most vendors won't tell you. ↓

More pharmacovigilance insights from people who live it.

From physician-led videos to practical guides and regulatory updates, everything in our Knowledge Hub is designed to help you make confident, informed decisions.

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