Signal detection refers to a process with an aim to identify any sign of an unexpected safety problem. As part of risk mitigation/minimization, this refers to an important step in Pharmacovigilance (PV). These signals can be found in new Adverse Drug Reactions (ADRs) or a change in the frequency of ADRs that are already known to be associated with the drug. In such scenarios, a signal strategy must be adapted to address every medicinal product’s safety profile, its stage in the lifecycle, and must line up with a precise risk-based signal management process to guarantee proper signal prioritization, escalation and timely decision making.
With an expert safety team, Freyr strategizes and implements the best risk mitigation plans and analyzes to understand safety information for early signal detection. Freyr specializes in implementing a fool-proof signal management process right from signal detection to evaluation.
- Safety output generation from safety database for signal detection.
- Review and triage of routine signal detection safety outputs
- Quantitative signal detection using disproportionally analyses
- Signal detection and evaluation
- Signal validation and prioritization
- Signal assessment and recommendations which includes risk classification and proposals for risk minimization measures
- Risk management strategy development, planning, execution and evaluation
- Use of tools for signal detection activities and signal management tracking
- Single point of contact for the entire range of safety services including ICSR, Aggregate reports, Qualified Person Responsible for PV (QPPV) services, the US Agent services, Signal Detection & Evaluation, database migration, adverse event reconciliation, and local affiliate services
- Initial kick-off to submissions to Health Authority (HA) and handling/addressing HA queries
- In-depth safety knowledge perfectly integrated with required IT capabilities
- Expertise in ICSR case management including case triage/book-in, case processing, narrative writing, medical review, quality control and submission
- Staff with hands-on experience in handling/managing standard and customized safety databases like Aris G, Oracle Argus, Adverse Event Reporting System (AERS), FDA's AERS (FAERS), SCEPTRE, Empirica Trace, Sapphire, Clintrac to name few
- Expertise in writing aggregate safety documents as per various health authority and submission requirements like Periodic Safety Update Report (PSUR), Periodic Benefit Risk Evaluation Report (PBRER), Development Safety Update Report (DSURs), Periodic Adverse Drug Experience Report (PADERs), Annual Safety Report (ASRs), Risk Management Program (RMPs), Risk Evaluation and Mitigation Strategy (REMS), any other country specific reports, etc.
- Expertise in setting up PV systems and processes, PV Database Evaluation, PV Database Validation, Harmonization, writing SOPs and training employees as per local Regulatory requirements in various geographies
- Experience in conducting mock audits, training on facing inspections, support in preparing Corrective and Preventive Action (CAPA) and remediation activities
- Extensive experience in PV process harmonization and creation of Company Core Data Sheet (CCDS) and Core Safety Information (CSI)
- Experience in tracking safety variations and PV System Master File (PSMF) compliance
- Defined processes of thorough scientific, medical, editorial and quality control review
- Timely delivery with the highest standard of quality
- Expert program and project management support to maintain compliance