Safety Science Analyst

As a Clinical Safety and/or PSS Operations Assistant at Fortrea, your role will involve assisting with the overall Clinical Safety and/or PSS operations associated with products, including managing the entire adverse events process. Your responsibilities will include: - Performing case intake and triage of incoming safety information or reports from various sources - Data entry of safety data onto adverse event tracking systems - Writing patient narratives and accurately coding adverse events using MedDRA - Assisting in the listedness assessment against appropriate label - Generating queries and collecting missing or discrepant information in consultation with medical staff - Submitting expedited SAE reports to various stakeholders within agreed timelines - Processing and submitting expedited and periodic reports to worldwide regulatory agencies or other recipients - Reconciling databases as applicable - Working within the Quality Management System framework - Maintaining supporting files/documentation regarding adverse event reporting requirements - Supporting upload/archival of case/study/project documentation - Building and maintaining good PSS relationships across functional units - Supporting compliance of operations with governing regulatory requirements - Performing any other duties as needed or assigned Qualifications Required: - Healthcare professionals with 0 to 6 months of relevant experience - Relevant degree in disciplines such as Pharmacy, Nursing, Medical Sciences, Life Sciences, or related area - Safety experience in processing AE/SAE reports, generating narratives, queries, working within safety databases, and experience with regulatory submissions Experience Required: - Attention to detail - Team player - Solid written and verbal communication skills - Accurate math and spelling skills - Knowledge of MS Office Windows applications - Ability to operate standard office equipment Please note that this job involves working in an office environment. For more information about EEO & Accommodations requests, you can learn more on our website.,