Found Description
ICON plc is a world-leading healthcare intelligence and clinical research organization.
We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
**What you will be doing**:
- Receives and processes individual case safety reports ((ICSR; e.g. serious adverse events, adverse events of special interest, and suspected ADRs) from clinical trial, spontaneous and from published reports.
This includes: Tracking of received ICSR, entry of ICSR into company or client safety database and query management.
- Performs consistent coding of diseases, adverse events, and medications according to the project-specific coding conventions in the Safety Database.
- Assesses reportability of ICSRs based on the project-specific Safety Reporting Assessment sheet.
- Submits safety reports to Regulatory Authorities, IRB/ECs, and investigational sites in accordance wit...