As a Safety Science Analyst, you will assist with the overall Clinical Safety and/or PSS operations associated with products, including the entire adverse events process. This may involve safety data collected from clinical trials and/or post-marketing settings. You will manage and process expeditable adverse events to the required standard and submit them to clients and/or regulatory agencies within the agreed timelines. The role demands providing clients with the appropriate quality of service in a safe and cost-effective manner.
Key Responsibilities:
- Perform case intake and triage of incoming safety information or reports from various sources.
- Assist with processing adverse events, including:
- Data entry of safety data onto adverse event tracking systems.
- Writing patient narratives and coding adverse events accurately using MedDRA.
- Listedness assessment against appropriate labels for marketed products.
- Generating queries and collecting missing or discrepant information in consultation with medical staff.
- Submission of expedited SAE reports to clients, regulatory authorities, ethics committees, investigators, 3rd party vendors, partners, and Fortrea project personnel within agreed timelines.
- Assist in the reconciliation of databases.
- Work within the Quality Management System framework, including Standard Operating Procedures (SOP) and departmental Work Instructions (WIs).
- Maintenance of supporting files/documentation regarding adverse event reporting requirements in all countries.
- Support upload/archival of case/study/project documentation.
- Build and maintain good PSS relationships across functional units.
- Support compliance of operations with governing regulatory requirements.
- Perform all other duties as needed or assigned.
