Safety Signal Detection Services

The pharmacovigilance signal detection management process is a set of activities performed to determine whether there are new risks associated with a medicinal product or whether known risks have changed based on the examination of Individual Case Safety Reports (ICSRs), aggregated data from active surveillance systems or studies, and scientific literature information or other data sources. It also includes related recommendations, decisions, communications, and tracking. In such scenarios, a signal management process must be adopted to address every medicinal product’s safety profile and lifecycle stage, and it must line up with a precise, risk-based pharmacovigilance signal management strategy to guarantee proper signal prioritization, escalation, and timely decision-making.

The pharmacovigilance signal management process includes activities such as signal detection, signal validation, signal confirmation, signal analysis and prioritization, signal assessment, and recommendations for action.

With an expert drug safety team, IGRS strategizes and implements the best risk-mitigation plans and analyses the safety information for early signal detection.

IGRS is specialized in implementing fool-proof signal management in the pharmacovigilance process, right from drug safety signal detection to evaluation.

The signal detection scientist collaborates with you to develop a signal detection management plan and implement a robust signal monitoring and management process that addresses the needs of the proposed products.

 

IGRS Expertise

• A global safety database line listing and summary tabulations for signal detection process in Pharmacovigilance.

• Qualitative signal detection using a case-by-case analysis.

• Review of ICSRs, aggregate reports, as well as Pharmacovigilance Risk Assessment Committee (PRAC)recommendations on safety signals included in pharmacovigilance signal management, safety updates on the Health Authority websites, and literature review for evaluation of safety information.

• Identification of a new safety signal or a change in risk associated with a medicinal product.

• Validating an identified safety signal and reviewing processes such as determination of causality, evaluation of frequency, and strength of evidence for a causal effect.

• Accurate interpretation of safety data and confirming the signal in coordination with the safety committee of the MAH periodically.

• Signal assessment and recommendations, which include risk classification and proposals for risk minimization measures.

• Risk management strategy development, planning, execution, and evaluation.