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Pharmacovigilance Signal Detection. Act Before It Matters

Our pharmacovigilance signal detection practice is led by Paulina Valuskova, Ph.D., pharmacist, researcher, and Deputy EU QPPV. She and her team combine advanced analytics, AI-assisted screening, and structured medical review so emerging signals are caught early, assessed with rigor, and backed by decisions that are documented and defensible.

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PHARMACOVIGILANCE SIGNAL DETECTION

Signals, detected, reviewed,
and actioned.

Paulina and her team provide end-to-end signal management support, from advanced detection and medical evaluation through to structured communication and full audit trails, so no signal goes unaddressed and every decision is documented and defensible.

Signal Detection

We use advanced analytics, AI-assisted screening, and structured prioritisation to help you detect true signals earlier, so you can focus on trends that deserve your attention and act quickly when it counts.

Signal Validation & Evaluation

We validate and assess potential signals using medical insight, epidemiology, and statistical review, so you understand clinical relevance, benefit–risk impact, and whether action is needed, backed by sound reasoning.

Signal Tracking & Audit Trails

We set up complete tracking, documentation, and audit trails so every decision is traceable, consistent, and inspection-ready, giving you confidence that your signal work will stand up under scrutiny.

Signal Augmentation

We strengthen interpretation by combining your internal data with external sources including EudraVigilance, FAERS, VigiBase, literature, and real-world data, giving you context instead of isolated alerts, and clarity instead of gaps.

Signal Communication

We help you prepare structured communication for regulators, partners, affiliates, and internal teams, so your decisions are understood, aligned, and easy to defend under scrutiny.

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