PV Consulting

Pharmacovigilance doesn’t have to feel impossible.

Hi, I’m Marcela Fialova, MD. I help pharma and biotech teams build PV systems that are clear, compliant, and practical; systems that fit your reality. Whether you’re setting up from scratch, transitioning between vendors, or trying to regain control, I’ll help you find structure and confidence without overcomplicating things.

Marcela Fialova, MD

Physician | PV System Specialist | iVigee Co-Founder

20+ years of pharmacovigilance experience across pharma, biotech, and CROs, supporting system builds, transitions, and inspections.

Marcela Fialova, MD

Physician | PV System Specialist | iVigee Co-Founder

20+ years of pharmacovigilance experience across pharma, biotech, and CROs, supporting system builds, transitions, and inspections.

You deserve clarity, not consulting jargon.

I’m a physician and co-founder of iVigee. Before that, I worked on both the pharma and vendor sides of pharmacovigilance, which means I’ve seen the challenges you’re up against, from every angle.

Over the years, I’ve helped clients like you set up new PV systems, manage global-to-local transitions, and recover from audits when everything felt at risk, including building a compliant system from scratch in just two weeks.

What I’ve learned is simple: when you understand why something matters, compliance becomes a tool, not a burden. My role is to bring that clarity, structure, and peace of mind to your day-to-day work.

MD, 1st Medical Faculty

Charles University, Prague

20+ Years of Pharmacovigilance Experience

Across pharma, biotech, and CRO environments

DIA Pharmacovigilance Training Faculty

Delivering practical, real-world PV education

PV System Alignment & Governance

System transitions, oversight models, and inspection readiness

You’re under pressure to do it all, and it’s not getting easier.

You’re balancing regulations, vendors, audits, affiliates, all while new guidance keeps appearing. You want a system that runs smoothly, but every fix seems to add more complexity. I know how that feels.

You’re under pressure to do it all, and it’s not getting easier.

I’ve been there, managing expectations, solving problems no one planned for, and trying to keep everything inspection-ready without losing momentum.

My goal is to help you cut through that noise and build a PV system that gives you control, not more work.

Marcela Fialova, MD

Consultant & Co-Founder, iVigee

Let’s make your PV system work for you, not the other way around.

Every company’s setup is different, but the outcome is the same: a PV system that’s compliant, sustainable, and easy to manage.

PV System Design & Optimization

Build or refine frameworks that fit your processes, structure, and people.

Transition Management

Move between vendors or affiliates without losing oversight or quality.

Governance & Oversight

Strengthen accountability and transparency while keeping operations efficient.

Audit & Inspection Readiness

Identify and fix issues before they turn into findings.

Team Enablement

Turn lessons from audits into sustainable operational improvements.

We’ll work step by step. You’ll understand every decision and see measurable progress.

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

Transparent Pricing

$563/hour

Per hour consultation rate

Marcela Fialova, MD

Consultant & Co-Founder, iVigee

20+ years of pharmacovigilance experience across pharma, biotech, and CROs, supporting system builds, transitions, and inspections.

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

I’ll listen first, ask the right questions, and tell you clearly where you stand. You’ll leave every session with structure and next steps you can act on immediately.