iVigee » Pharmacovigilance Consulting » Jan Petracek

Regulatory Insight. Real-World Results.

As former Head of Risk Management at EMA, I spent a decade shaping the EU and global PV regulations your team works within every day. I've since built over ten PV systems, led hundreds of audits and inspections, and guided companies through their most critical moments. I'm a pragmatic optimist, I'll help you find the right path and focus your resources on the work that actually matters.

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Experience built inside the industry's most respected organizations.

EXPERTISE

Dr. Jan Petracek's Expertise

Every organisation I work with is carrying too much low-value activity and not enough focus on what truly matters. I'll help you identify what's working, remove what isn't, and build a PV function that protects patients and makes your team feel confident, not overwhelmed.

Signal & Risk Management

Signal management and risk management are where I've spent much of my career, as a regulator, as an EU QPPV, and as a strategic advisor. I'll help you make critical safety decisions with clarity and structure, and build the processes that support them long-term.

Pharmacovigilance Transformation

I've led major transformation programmes across companies of all sizes. I'll help you identify the activities that drain resources without adding value, and redirect your team's effort toward the highest-impact work.

AI Guidance & Implementation

AI is changing pharmacovigilance fast, and most organisations don't yet know where it helps and where it creates risk. I'll help you understand the landscape honestly, implement it safely, and make sure human judgement stays where it must.

Strategic Pharmacovigilance Advisory

Most organisations know something isn't working but struggle to see the whole picture. I'll help you step back, understand what truly matters, and build a strategic roadmap your team can actually deliver, without overcomplicating it.

EU QPPV Oversight & Leadership

I've served as EU QPPV across small biotech and large innovative pharma for 15 years. I provide the oversight, governance, and leadership your organisation needs to stay compliant and inspection-ready across your entire product portfolio.

Inspection and Crisis Management

I've managed countless inspections, withdrawn unsafe products as a regulator, and helped companies recover from critical findings that threatened their entire portfolio. When the pressure is highest, I'll help you stabilise, respond, and get back on track.

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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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. ↓

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