PV Consulting

Pharmacovigilance should protect patients, not bury teams in noise

Hi, I’m Dr. Jan Petracek. I help organizations focus on what truly matters in pharmacovigilance: building systems that protect patients, stand up in inspections, and free your teams to spend time on decisions that make a real difference.
Jan Petracek
MD | Global PV Leader | Former Regulator | EU QPPV

Former Head of Risk Management at EMA, former CEO of PrimeVigilance, and contributor to global pharmacovigilance standards including ICH and CIOMS guidelines.

You deserve a PV advisor who has shaped the system, not just worked within it.

I’ve spent more than 25 years leading, designing, and improving pharmacovigilance at every level — as a regulator, as an EU QPPV, as a CEO, and now as the founder of iVigee.

Earlier in my career, I helped shape EU and global PV policy, led the enlargement of the EU pharmacovigilance system, and contributed to cornerstone guidelines including ICH E2F, CIOMS IX, and early EU GVP drafts.

I’ve built PV systems from scratch for companies of all sizes, led inspections and crisis response, and delivered major transformation programs that strengthened compliance while making teams more effective.

My goal is always the same: clarity, strategy, and solutions that protect patients and help organizations thrive.

MD in General & Preventive Medicine

Medical background with lifelong focus on patient safety

MSc with Distinction in Quality & Safety in Healthcare

Imperial College London

Fellow, International Society of Pharmaco
vigilance

Recognized for sustained contribution to global PV

Global Fellow in Medicines Development

King’s College London & IFAPP Academy

DIA Trainer (20+ years)

DIA Excellence in Service Award (2018)

Former Head of Risk Management

European Medicines Agency (EMA)

Former CEO, PrimeVigilance

Led company to receive Queen’s Award (2019)

Holder of all major PV certifications

Extensive professional credentials

If you’re responsible for PV today, you’re probably carrying more weight than anyone realizes.

Many organizations face the same pressures: too little recognition for PV, too few resources, and systems that are either over-engineered or not strong enough.
CIOMSCIOMS
EMAEMA
FDAFDA
Health CanadaHealth Canada
ICHICH
MHRAMHRA
PMDAPMDA
WHOWHO

If you’re responsible for PV today, you’re probably carrying more weight than anyone realizes.

Many organizations face the same pressures: too little recognition for PV, too few resources, and systems that are either over-engineered or not strong enough.

Teams are stretched. Deliverables pile up. Critical thinking gets buried under administrative work.

I’ve seen this struggle in hundreds of companies. In most cases, it’s not the people — it’s the system.

The real challenge is identifying what truly matters, removing what doesn’t, and redirecting effort toward the activities that protect patients and create value.

That’s where I come in.

Henry Seto
Jan Petracek
Founder & Principal Consultant, iVigee

Let’s rebuild your PV function around what truly protects patients — and what truly matters.

Every organization’s challenges are different, but the goal is always the same: a PV system that is compliant, efficient, and focused on value, not noise.
Signal & Risk Management Expertise
Signal & Risk Management Expertise
Make critical decisions with clarity, structure, and confidence.
Strategic PV Advisory & Roadmaps
Strategic PV Advisory & Roadmaps
See the whole system, understand what matters most, and build a plan your team can deliver.
Business & PV Transformation
Business & PV Transformation
Remove low-value activities, streamline operations, and focus resources where they have the biggest impact.
EU QPPV Oversight & Leadership
EU QPPV Oversight & Leadership
Ensure safety, compliance, and strong governance across the product lifecycle.
AI Guidance & Implementation
AI Guidance & Implementation
Understand where AI helps, how to use it safely, and where human judgment must always lead.
Together, we’ll simplify what’s overcomplicated, strengthen what’s weak, and build a PV function that makes your team feel confident — not overwhelmed.

What it costs to work with me

Hi, I’m Dr. Jan Petracek. I help organizations focus on what truly matters in pharmacovigilance: building systems that protect patients, stand up in inspections, and free your teams to spend time on decisions that make a real difference.
Transparent Pricing
$1167/hour

Consulting is billed hourly. Most clients start with a focused session to address a specific challenge, then expand as clarity and impact grow.

Jan Petracek
Founder & Principal Consultant, iVigee

Former Head of Risk Management at EMA, former CEO of PrimeVigilance, and contributor to global pharmacovigilance standards including ICH and CIOMS guidelines.

What to Expect When Working with Me

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.

Jan Petracek
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The Process – How It Works

Everything starts with listening. From there, we focus on what will have the biggest impact on patient safety and system performance.
Book a session
Choose a time that works for you.
Share the context
A short intake form helps me prepare.
Get actionable guidance
We meet, talk openly, and build a plan you can act on immediately.
No sales pitch. Just clarity, experience, and honest advice.

Ready to make PV strategic, effective, and truly impactful again?

No sales pitch. Just a clear conversation about your PV challenges — and what we can do about them together.

Practical resources to help you make better PV decisions

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