Pharmacovigilance Signal Detection Management Services - Overview
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, Freyr strategizes and implements the best risk-mitigation plans and analyses the safety information for early signal detection. We specialize in implementing fool-proof signal management in the pharmacovigilance process, right from drug safety signal detection to evaluation.
Pharmacovigilance Signal Management Services
- Qualified experts (medical doctors, pharmacy and life sciences graduates) with domain knowledge
- Experience in signal management activities such as signal detection, validation, prioritization, and assessment
- Ability to work with both qualitative and quantitative signal analysis
- Ability to handle large data from external signal sources such as FAERs, Eudravigilance, Vigibase etc.
- Preparation and review of signal detection and evaluation reports
- Preparation and review of ad hoc reports such as medical opinion memos and health hazard evaluation reports
- Participation in decision-making for risk management and communication
- Support for risk communication and creation of responses to health authority questions
- Robust documented processes governing signal management which can be customized as per client requirements
- Design and implementation of technology, templates, and procedures required for signalling
- Quality management processes for ensuring high-quality deliverables
- Expert review by highly experienced medical doctors to ensure the accuracy and consistency of scientific interpretations and conclusions
