,Pharmacovigilance (PV) Signal Detection Services - Overview
A structured approach to Pharmacovigilance (PV) Signal Detection Services is critical to monitoring a product’s evolving safety profile. Signal Management activities involve identifying whether there are new or changing risks based on ICSRs, aggregated safety data, and scientific literature. Freyr’s process ensures proper signal validation, prioritization, and escalation to enable timely decision-making.
Our experts access and analyse quantitative data from regulatory databases such as EVDAS, FAERS, and Vigibase to perform qualitative signal detection and author scientific Signal Detection and Evaluation Reports. This comprehensive approach guarantees regulatory compliance while maintaining patient safety.
Pharmacovigilance (PV) Signal Detection Services
- End-to-end signal management services, from signal strategy creation, detection, evaluation and recommendations of actions
- Expertise in signal validation, confirmation, prioritization, and assessment
- Preparation and review of Signal Detection Report and Signal Evaluation Report
- Capability to process large data sets using data mining tools and databases such as EMPIRICA, EVDAS, FAERS, and Vigibase
- Support for risk communication and regulatory responses
- Well-documented processes for Signal Detection and Management in Pharmacovigilance
- Technology-driven workflows, custom templates, and automated tracking
- Expert medical review for scientific accuracy and causality assessment
- High-quality deliverables and adherence to global compliance standards
Freyr’s Pharmacovigilance Signal Detection expertise ensures early identification of potential drug safety risks and effective implementation of mitigation strategies. Our specialized Signal Detection and Management Services in Pharmacovigilance enable faster decision-making, regulatory confidence, and enhanced patient safety outcomes.
