Safety Science Specialist
2 weeks ago
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.
The below statements are intended to describe the general nature of the job and are not intended to be an exhaustive list of all responsibilities, skills and duties*.
Manage the receipt and processing of all adverse event reports reported either spontaneously from any source or solicited from a clinical trial. This includes, but is not limited to: Data 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 listedness against appropriate label (for Marketed products, if applicable) Identifies clinically significant information missing from the reports and ensures its collection; Prepare follow-up correspondence in consultation with the medical staff, as needed Ensure case receives appropriate medical review Ensure all cases that require expediting reporting to worldwide regulatory agencies and other required parties are processed swiftly and appropriately within required timelines Reporting of endpoints to clients, regulatory authorities, ethics committees,investigators, 3rd party vendor, Partner and Fortrea project personnel, if required, within study specified timelines Submission of expedited Serious Adverse Event (SAE) reports to clients, Regulatory Authorities, Ethics Committees, investigators, 3rd party vendors, Partners and Fortrea project personnel, if required & as agreed with client during study set-up, within study specified timelines Assist or contribute to Database reconciliation in liaison with Data Management team or clients Manage processing of Expedited Safety Reports (ESRs), Periodic Safety Reports (PSRs) and submission, includes but not limited too. Maintenance of adverse event tracking systems Set-up and maintenance of project files and central files for documentation Assist with the reporting of ESRs & PSRs to clients, Regulatory Authorities, Ethics Committees, investigators and Fortrea project personnel, as required, within study specified timelines Perform quality review or peer review of processed reports and support the Line Management with trends and actions needed Maintains a comprehensive understanding of Standard Operating Procedures (SOPs), Work Instructions (WI), guidance documents and directives associated with safety management, reporting and pharmacovigilance Assist in the generation and maintenance of the PSS metrics Support preparation for client meetings and liaise with clients where appropriate. Assist with the set-up of, and the provision of data to Safety Committees/DSMBs as applicable. Prepare and support coordination of safety study files for archiving at completion of projects Support Root cause analysis and CAPA plan development for the identified quality issues, as needed Support and/or participate in audits and inspections including the preparation, as needed Demonstrate role-specific Core Competencies and company values on a consistent basis Build and maintain good PSS relationships across functional units Any other duties as assigned by management.
The above job duties are completed by the staff as applicable, depending on the role they are assigned to.
Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact.
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