Pharmacovigilance Risk Management

Pharmacovigilance Risk Management, Built on Evidence

Our pharmacovigilance risk management practice is led by Paulina Valuskova, Ph.D., pharmacist, researcher, and Deputy EU QPPV, bringing the regulatory precision and operational discipline this work demands. Paulina and her team ensure your RMPs, systems, and risk minimization measures are built on real evidence, designed to hold up under scrutiny, and easy to stand behind.

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Quality systems built to satisfy the world's most demanding regulators.

PHARMACOVIGILANCE RISK MANAGEMENT

Risks, documented, minimized,
and defended.

Paulina and her team provide end-to-end risk management support, from developing and maintaining RMPs and standing up compliant risk systems, to designing and evaluating additional risk minimization measures, so your obligations are met, your decisions are defensible, and nothing slips through the cracks.

RMPs: Development, Updates & Lifecycle
Management

We help you develop, update, and maintain Risk Management Plans that reflect real evidence, global expectations, and the realities of your product, so you can stand behind every decision with confidence.

aRMMs: Design, Execution & Effectiveness Evaluation

We help you design practical Additional Risk Minimization Measures (aRMMs), coordinate rollout, and evaluate effectiveness using evidence regulators trust, so your measures are meaningful, compliant, and easy to explain.

Risk Management Systems: End-to-End Setup, Implementation & Oversight

We help you design and run an end-to-end risk management system that actually works, from governance and processes to coordination and documentation, so you always know where things stand and nothing slips through the cracks.

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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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Does It Really Matter if My PV Vendor Is Physician-Led?

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. ↓

More pharmacovigilance insights from people who live it.

From physician-led videos to practical guides and regulatory updates, everything in our Knowledge Hub is designed to help you make confident, informed decisions.

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