Detecting and analysing changes.

Signal Management

Continuous safety vigilance. 

Unknown risks can occur at any time when a product is marketed among the general population, so looking for new safety issues is essential.

Systematic data-based evaluation.

Signal management is a vital ongoing part of pharmacovigilance involving the continuous monitoring, assessment, and discovery of potential safety concerns with a medicinal product.

It is a detailed process that scrutinises the data from various sources, including individual case safety reports (ICSRs), aggregated data from active surveillance systems or studies, scientific literature information, and other relevant sources.

Its objective is to look for patterns, circumstances, and other commonalities to uncover any safety ‘signals’ that may indicate a new medicinal product risk.

This systematic approach enables regulatory authorities and pharmaceutical companies to identify and communicate emerging safety concerns before they pose significant risks to patients.

In the EU, signal management follows a series of steps that offer a standardized approach including signal detection, validation, confirmation, analysis and prioritization, assessment, and recommendations for action.

A complete service, now and for the future.

iVigee’s Signal Management service combines years of experience and expertise with the precision of our Safety Database analytics system, iViSight, to go beyond standard solutions with enhanced detection capabilities, efficiency, and precision.

By blending human insight with advanced technology, we can provide a comprehensive, future-ready solution for PV and Signal Management service that meets the growing complexity and volume of pharmacovigilance data.

Our approach is always focused on aligning your unique needs, while maintaining the highest level of patient safety and compliance with global regulatory standards.

Contact us about our Signal Management services.

Whatever your Signal Management requirements, our experienced pharmacovigilance experts can provide the solution.

Email us at or fill in and submit the form below.

Our Business Development team will respond within one working day.

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