iVigee » Pharmacovigilance Consulting » Marcela Fialova

Pharmacovigilance doesn't have to feel impossible

Pharmacovigilance doesn't have to feel impossible.

As a physician, co-founder, and someone who's worked on both sides of PV, at a CRO and at pharma, I've seen every kind of challenge. Whether you're building from scratch, transitioning between providers, or facing an inspection, I'll help you find the clearest path forward without overcomplicating it.

Ask Marcela a Question

Experience built inside the industry's most respected organizations.

EXPERTISE

Dr. Marcela Fialova's Expertise

Every client I work with is different, and that's exactly what I find interesting. I'll take the time to understand your situation, your plans, and what you're trying to achieve, then help you find the most practical path to get there.

PV System Design & Setup

Every company's PV system is different, and the right solution depends on your stage, structure, and geography. I'll help you design something that fits your reality, not a template someone else built for a different company in a different situation.

Transition Management

Moving between MAHs, vendors, or affiliates is one of the highest-risk moments in PV. I've led complex transitions and know how to keep compliance intact and operations running smoothly while everything around you is changing.

EU Market Entry & QPPV Support

I've supported the introduction of innovative products onto the EU market from the position of EU QPPV. I'll help you understand exactly what's required for your geographical coverage, what can wait, and how to get there without unnecessary overhead.

Vendor & Partner Management

I've worked on both sides of the provider relationship, which means I know where things go wrong and why. I'll help you set up oversight that actually works, so your vendors and partners deliver what you need, consistently and accountably.

Audit & Inspection Readiness

I've helped clients recover from critical inspection findings, including building a fully compliant PV system in just two weeks to prevent product withdrawal. I'll help you identify gaps early and close them before they become findings.

Governance & Compliance

PV doesn't sit in isolation, it touches every department, every vendor, and every market you operate in. I'll help you build the governance structures that keep everything connected, accountable, and inspection-ready as your business grows.

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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