Signal Management

Signal Management in pharmacovigilance refers to the systematic process of detecting, assessing, understanding, and communicating new or changing safety issues related to medicinal products. Robust signal management processes are essential for proactive risk identification and management throughout the lifecycle of medicinal products, contributing to improved patient safety and healthcare outcomes.

It is a set of activities performed to determine whether, based on an examination of Individual Case Safety Reports (ICSRs), aggregated data from active surveillance systems or studies, scientific literature information or other data sources, there are new risks associated with an active substance or a medicinal product or whether known risks have changed, as well as any related recommendations, decisions, communications and tracking.

Signal Management

Signal Management in pharmacovigilance refers to the systematic process of detecting, assessing, understanding, and communicating new or changing safety issues related to medicinal products. Robust signal management processes are essential for proactive risk identification and management throughout the lifecycle of medicinal products, contributing to improved patient safety and healthcare outcomes.

It is a set of activities performed to determine whether, based on an examination of Individual Case Safety Reports (ICSRs), aggregated data from active surveillance systems or studies, scientific literature information or other data sources, there are new risks associated with an active substance or a medicinal product or whether known risks have changed, as well as any related recommendations, decisions, communications and tracking.

We adhere to rigorous signal management processes to comply with both global and local regulatory standards. Our support for sponsors encompasses a broad spectrum of activities, including signal detection from various sources, signal validation, and signal analysis and prioritization.

The signal management process
includes following steps:

Signal Analysis & Prioritization

Signal Validation

Signal Detection

Exchange of Information

Recommendation for Action

Signal Assessment

Related Insights

Risk Management

Risk management in pharmacovigilance plays a pivotal role in safeguarding patient well-being…

Literature Search

Offering global and local literature monitoring services to identify adverse events throughout the product life cycle.

Aggregate Reporting

Regulatory bodies mandate the sponsors/MAHs to submit safety information in applicable…