Signal Management
Signal Management in pharmacovigilance is the structured process of detecting, evaluating, understanding, and communicating potential or established safety risks related to medicinal products. It ensures early identification and proactive management of safety issues, strengthening patient protection and healthcare outcomes throughout a product’s lifecycle.
Our team performs a comprehensive range of activities, including the review of Individual Case Safety Reports (ICSRs), analysis of aggregated safety data, literature screening, and monitoring from various sources. We follow a robust and compliant signal management framework aligned with both global and local regulatory requirements.
Our Signal Management Process includes the following steps:
Signal Detection
Identifying new or changed safety information from multiple data sources.
Signal Validation
Confirming the relevance and accuracy of the detected signal.
Signal Analysis & Prioritization
Evaluating data significance and assigning risk levels.
Signal Assessment
Assessing causality, clinical impact, and regulatory implications.
Recommendation for Action
Proposing appropriate risk minimization or communication steps.
Exchange of Information
Ensuring timely updates to stakeholders and regulatory authorities.
