Dr. Jan Petracek, Former Head of Risk Management, EMA

Pharmacovigilance Solutions From Those Who Wrote the Rules

We deliver pharmacovigilance solutions to pharmaceutical and biotech companies worldwide, led by physicians who helped write the global regulations you're held to today. You're not hiring consultants who follow the rules. You're working with the people who shaped them.

Meet the Physicians

Our PV Solutions

Every market. Every authority. Local expertise on the ground.

THE TEAM LEADING OUR WORK

iVigee is led by physicians, not financiers, and that won't change.

Our leadership comes from medicine and drug safety, not finance backgrounds. That means patient safety drives the decisions, and the people you trust today are the same ones accountable tomorrow.

Dr. Henry
Seto

Chief Medical
Offiicer

Cardiologist and Chief Medical Officer with 25+ years in drug safety and medical affairs. Henry helps companies build global safety strategies that are compliant, scalable, and clinically sound.

If you need clinical judgment and operational clarity working together in your pharmacovigilance system, Henry brings both.

Dr. Marcela
Fialova

Co-Founder & Chief Operating
Officer

Physician with 20+ years across pharma, biotech, and CROs. Marcela helps teams build clear, compliant pharmacovigilance systems that fit their reality and stand up under scrutiny.

If your Pharmacovigilance system feels harder to manage than it should be, Marcela will find the gaps and fix them.

Dr. Natalia Kalousova Kocankova

SVP PV Ambasador, Head of PV Operations

Physician with 20+ years supporting global PV teams. Natalia brings clarity and structure to pharmacovigilance strategy and compliance so teams feel confident, not buried in process.

If regulatory complexity is slowing your team down, Natalia turns it into something clear and actionable.

Dr. Jan
Petracek

Founder & Chief Executive
Officer

Former Head of Risk Management at EMA and contributor to ICH and CIOMS guidelines. Jan helps organizations cut through complexity and build PV systems that protect patients and stand up in inspections.

If your PV system needs strategic direction from someone who helped shape the rules it operates under, Jan is who you call.

PHARMACOVIGILANCE SOLUTIONS

Two ways we can help. Which fits
your situation?

From complete, managed pharmacovigilance solutions to targeted support that fills a single gap, choose the model that matches where you are and what you need.

BUILD. OPTIMIZE. TRANSFORM.

Pharmacovigilance Services

Whether you're building your pharmacovigilance function from the ground up, tightening what you already have, or ready to transform how it operates entirely, we support the full product lifecycle and meet you at every stage.

You need expert PV support, whether that's a single function or an entire department
You need inspection-ready processes and can't afford gaps in your compliance

Services

ASSESS. ADVISE. DELIVER.

Pharmacovigilance Consultancy

Not sure where your PV system stands? Our physicians and scientists will assess what you have, advise on what needs to change, and deliver a clear plan you can act on with confidence, no jargon, no guesswork.

You have a PV function but need expert eyes on whether it's truly fit for purpose
You have internal resource to execute but need a clear and confident plan to follow

Consultancy

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.

Actual iVigeeans ↑

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.

Start learning