.As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe. Job Overview: Assist with the overall Clinical Safety and/or departmental operations associated with products including the entire adverse events process: which may include safety data collected from clinical trials and/or post marketing setting (i.E., unsolicited reports). Ensure that for assigned projects, expeditable adverse events reporting is completed to the required standard and submitted to client and regulatory agencies (if required) within the agreed/stated timelines. It is the responsibility of the post holder to provide all clients, both internal and external, with the appropriate quality of service in a safe and cost-effective manner. Summary of Responsibilities: Oversee the receipt and processing of all adverse event reports reported either spontaneously from any source or from a clinical trial for assigned projects. Ensure compliant safety reporting in accordance with international reporting regulations, SOPs, and safety processing guidelines, for assigned projects. Maintain a strong understanding of Fortrea's safety database conventions or client-specific database conventions, as appropriate. Supports preparation of pharmacovigilance reports for products and safety issues, including Individual Case Summary Reports (ICSRs) of Serious Adverse Events (SAEs), Annual IND reports, Development Safety Update Report (DSUR) Periodic Safety Reports (PSRs) line listings, and aggregate reports. Actively participate in and demonstrate leadership on projects which enhance team and/or division performance. This will include acting as safety lead for projects at global or regional level, ensuring communication and process harmonization. Work with internal or external partners for reconciliation of safety databases, if appropriate. May support workflow monitoring for assigned studies/programs to ensure deadlines are met. Draft/modify and deliver safety presentations as required, to external and internal stakeholders. Maintains a comprehensive understanding of Fortrea departmental Standard Operating Procedures (SOPs), Work Instructions (WI), guidance documents and directives associated with safety management, reporting, and pharmacovigilance. Possess knowledge of other procedural documents, e.G., SOPs, etc. that impact department. Assist in the development of departmental Work Instructions (WI) and Standard Operating Procedures (SOPs), as appropriate
