- Case Intake and Triage:
- Manage the intake and triage of incoming safety information or reports from various sources, including spontaneous reports and clinical trials.
- Adverse Event Processing:
- Data entry of safety data into adverse event tracking systems.
- Write patient narratives and accurately code adverse events using MedDRA for marketed products, if applicable.
- Assist in listedness assessments against appropriate labels for marketed products, if applicable.
- Query Generation and Data Collection:
- Generate queries and collect missing or discrepant information in consultation with medical staff as needed.
- SAE Report Submission:
- Submit expedited SAE reports to clients, regulatory authorities, ethics committees, investigators, third-party vendors, partners, and Fortrea project personnel within agreed timelines.
- Report Processing and Submission:
- Assist in the processing and submission of expedited and periodic reports to worldwide regulatory agencies and other recipients, ensuring adherence to regulatory and study-specific timelines.
- Prioritize reports for processing and submission as required.
- Database Reconciliation:
- Assist in the reconciliation of databases as applicable.
- Quality Management:
- Work within the Quality Management System framework, including adherence to Standard Operating Procedures (SOPs) and departmental Work Instructions (WIs).
- Documentation Maintenance:
- Assist in maintaining supporting files/documentation regarding adverse event reporting requirements in all countries, if applicable.
- Support the upload and archival of case/study/project documentation as appropriate.
- Relationship Building:
- Build and maintain positive relationships across functional units within PSS.
- Support compliance of operations with governing regulatory requirements.
Candidate Profile: Fortrea is seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. We are dedicated to revolutionizing the development process and ensuring the swift delivery of life-changing therapies to patients. If you are looking to join an exceptional team and embrace a collaborative workspace where personal growth is nurtured, Fortrea is the place for you.
