Consultant

Let’s make Pharmacovigilance strategic, and doable

Whether you’re growing fast, preparing for inspection, or trying to make sense of fragmented processes, I’ll help you see the whole picture and get your system working for you
Henry Seto
M.D. | F.A.C.C. | F.A.C.P.

Hi, I’m Dr. Henry Seto, Chief Medical Officer and President of iVigee USA. I help pharma and biotech companies build global safety strategies that actually work day-to-day, compliant, scalable, and clinically sound.

You deserve a PV partner who’s seen every side of the system.

I’ve spent my career leading medical safety, pharmacovigilance, and signal management across start-ups, small biotech, and large pharma. As a cardiologist and long-time industry executive, I’ve been on both sides, the one setting strategy and the one making it work on the ground.

I’ve helped companies build and operate some of the first large-scale outsourced PV programs of their kind, integrating clinical insight with operational precision. What that means for you is simple: you’ll have someone who knows what “good” really looks like, and how to get you there efficiently and safely.

My goal is to make pharmacovigilance strategic again, not a compliance chore, but a system that protects patients and supports your business.

Fellow of the

American College 
of Cardiology

25+ years

of global experience in drug safety and medical affairs

Specialist in

medical safety, signal evaluation, 
and PV system oversight

If you’re leading PV today, you’re probably being pulled in every direction.

You’re balancing case processing, signal detection, vendors, affiliates, and the pressure to stay inspection-ready never lets up. Everyone expects you to have the answers, but no one gives you the time or clarity to fix the root issues.
CIOMSCIOMS
EMAEMA
FDAFDA
Health CanadaHealth Canada
ICHICH
MHRAMHRA
PMDAPMDA
WHOWHO

If you’re leading PV today, you’re probably being pulled in every direction.

You’re balancing case processing, signal detection, vendors, affiliates, and the pressure to stay inspection-ready never lets up. Everyone expects you to have the answers, but no one gives you the time or clarity to fix the root issues.

I’ve seen that struggle first-hand. Teams stretched thin, systems built in a hurry, and leaders left to manage the fallout. You don’t need more slides or theory, you need structure that works, a plan that’s realistic, and someone who’s done it before.

That’s where I come in.

Henry Seto
Henry Seto
Chief Medical Officer, iVigee

Let’s bring clinical sense and operational clarity back into your PV system.

Pharmacovigilance should be both scientific and practical, protecting patients while helping your teams move faster. Here’s how I help you achieve that balance:
PV System Strategy & Oversight
PV System Strategy & Oversight
Build or strengthen global frameworks that ensure consistency, efficiency, and compliance
Signal Evaluation & Risk Management
Signal Evaluation & Risk Management
Translate data into clear, defensible safety decisions.
Medical Safety Leadership
Medical Safety Leadership
Provide expert guidance that connects science, operations, and strategy.
Vendor & FSP Optimization
Vendor & FSP Optimization
Make sure your partners deliver what they promise: quality, accountability, and value.
Inspection & Audit Readiness
Inspection & Audit Readiness
Identify and close gaps before regulators do.
We’ll focus on what’s essential, simplify what’s overbuilt, and align everything around one goal: safety done right, for your patients and your business.

Here’s exactly what it costs, no waiting, no guessing.

Whether you’re growing fast, preparing for inspection, or trying to make sense of fragmented processes, I’ll help you see the whole picture and get your system working for you
Consultancy
$1167/hour

Every engagement is scoped clearly, what’s included, what’s optional, and what outcomes you can expect. Whether you need executive-level strategy or a structured review of your PV setup, you’ll see the numbers upfront so you can make an informed decision before we even talk.

Henry Seto
Chief Medical Officer, iVigee

Hi, I’m Dr. Henry Seto, Chief Medical Officer and President of iVigee USA. I help pharma and biotech companies build global safety strategies that actually work day-to-day, compliant, scalable, and clinically sound.

Here’s what you can expect when we work together.

When we start, I’ll ask you to tell me what’s happening, what’s working, what’s not, and where you need clarity. I’ll listen carefully, ask the questions that matter, and explain exactly where you stand.

You’ll leave every session with a clear plan and practical next steps, not theory or generic advice.

Henry Seto
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Here’s what working together 
looks like.

Most clients start with one specific issue, signal evaluation, inspection prep, or vendor oversight, and leave with clarity, structure, and a renewed sense of control.
Tell me what’s going on
You’ll complete a short form so I can prepare.
Get practical guidance
We’ll meet online, talk openly, and build a plan you can act on immediately.
Book a session. 
Choose a time that works for you.

Ready to make pharmacovigilance work smarter for you?

No sales pitch, just a straightforward conversation about your PV challenges and what we can do about them.

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Meet Henry

Chief Medical Officer, iVigee

Hi, I’m Dr. Henry Seto, I help pharma and biotech teams build global pharmacovigilance strategies that are clinically sound, regulator-ready, and designed to support your development timelines, not slow them down.