Fortrea is inviting applications from candidates to hire for the role of Safety Science Analyst on a contractual basis. Here is everything you need to know about the opportunity!
|Job Role||Safety Science Analyst|
|Last Date to Apply||Apply as soon as possible|
- Candidates should completed B.Pharm or M.Pharm
- Perform case intake and triage of incoming safety information or reports from various sources spontaneously or from a clinical trial.
- Assist with processing of the adverse events, including but not limited to:
- Data entry of safety data onto adverse event tracking systems
- Write patient narratives & code adverse events accurately using MedDRA (for Marketed products, if applicable)
- Assist in the listed ness assessment against appropriate label (for Marketed products, if applicable)
- Assist in the generation of queries and collection of missing or discrepant information in consultation with medical staff, if needed
- Submission of expedited SAE reports to clients, regulatory authorities, ethics committees, investigators, 3rd party vendors, Partners and Fortrea project personnel, as required within the agreed timelines
- Assist with processing and submission of expedited and periodic reports to worldwide regulatory agencies or other recipients (Clients, Regulatory Authorities, Ethics Committees, investigators and Fortrea project personnel etc), and prioritise the reports for processing and submission within the regulatory and/or study specific applicable timelines
- Assist in the reconciliation of databases, as applicable
- Work within the Quality Management System framework, including but not limited to Standard Operating Procedure (SOP), departmental Work Instructions (WIs) etc as appropriate
- Assist in the maintenance of supporting files/ documentation regarding adverse event reporting requirements in all countries, if applicable
- Support upload/archival of case/study/project documentation, as appropriate
- Build and maintain good PSS relationships across functional units
- Support compliance of operations with governing regulatory requirements
- Any other duties as assigned by management
How to Apply?
All interested and eligible candidates can apply for this opportunity by following the link as soon as possible: