Project Manager Drug Safety

Job Overview: Manage ‘Client’ or ‘Project’ specific PSS 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) for specified projects. Manage and process expeditable adverse events to the required standard and submit them to the client and the regulatory agencies (if required) within the agreed/stated timelines. The post holder is responsible for providing this service to clients either as a support function to the client project groups or as stand-alone business. Provide all clients, both internal and external, with the appropriate quality of service in a safe and cost-effective manner. The role will be expected to comply with the legal requirements of the Health and Safety at Work Act 1974, the COSHH regulations 1989 and EC (European Commission) Directives 1992/3 as documented in the Company’s Health and Safety Manual. Summary of Responsibilities: Provide leadership and management of global or regional projects ensuring that communications and processes are harmonized for assigned projects. Monitor and manage the workflow for assigned projects to ensure all deadlines are met and compliant safety reporting in accordance with international reporting regulations, Standard Operating Procedures (SOPs) and safety processing guidelines set forth by departmental management team. Responsible for making decisions regarding adverse event reporting within the guidelines of each assigned project. Work closely with the clinical operations and project management groups to ensure all PSS activities are performed according to the regulatory and contractual requirements. Provide oversight of the receipt and processing of all adverse event reports reported either spontaneously from any source or from a clinical trial for assigned projects. This includes, but is not limited to: Entry of safety data onto adverse event database(s) and tracking systems. Review of adverse events for completeness, accuracy, and appropriateness for expedited reporting. Write patient narratives. Code adverse events accurately using MedDRA. Determine expectedness/listedness against appropriate label. Identifies clinically significant information missing from initial reports and ensures its collection. Ensure case receives appropriate medical review. Prepare follow-up correspondence consulting with the medical staff accordingly. Ensure all cases that require expediting reporting to worldwide regulatory agencies are processed swiftly and appropriately within required timelines. Reporting of endpoints to clients, regulatory authorities, ethics committees, investigators and Fortrea project personnel, if required, within study specified timelines. Provide oversight of the management and processing of expedited safety reports (ESRs) for assigned projects. This includes, but is not limited to: Review and update adverse event…