iVigee » Pharmacovigilance Consulting » Natalia Kalousova

Global PV expertise, built for your stage and size

I work with companies at every stage, from early biotech to large pharma, and I know that the right PV solution depends on where you are, not just where the regulations say you should be. Hands-on, transparent, and practical every step of the way.

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Experience built inside the industry's most respected organizations.

EXPERTISE

Dr. Kalousova-Kocankova's Expertise

Every company I work with is at a different stage, in a different market, with different pressures. I'll take the time to understand your situation first, then help you build something that actually fits, without overcomplicating it.

Global PV System Setup

I've built global PV systems from scratch, including a full setup across 23 affiliates worldwide, ready for marketing authorisation in just three months. I'll help you design a system that works across regions without losing sight of local requirements.

Affiliate & Distributor Network Management

Managing PV obligations across a large partner network is a different challenge entirely. I've built strategies to manage over 300 distributors and licensing partners, and I'll help you set up oversight that scales without creating operational chaos.

GVP & GCP Regulatory Compliance

Regulations change constantly, and staying ahead of them while keeping operations running is one of the hardest parts of PV. I'll help you build processes that are compliant today and flexible enough to adapt as requirements evolve.

Development to Post-Marketing Transition

The move from clinical to commercial is one of the most complex moments in a product's lifecycle. I've guided multiple US biotech companies through this transition into the EU market, and I'll help you navigate it without unnecessary risk or delay.

EU Market Entry & QPPV Support

I've served as EU QPPV for multiple companies entering the EU market, including navigating named patient sales and compassionate use complexities. I'll help you understand exactly what's required and get there efficiently.

Reference Safety Information & Risk Minimization

Getting your RSI strategy right and managing additional risk minimisation measures is critical and often underestimated. I'll help you build a clear, defensible approach that satisfies regulators and works for your teams in practice.

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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