Lead Safety Science Specialist Full-time Job

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 including safety database entry, AE review,

write patient narratives with coding, follow-up of missing information, listedness assessment

against appropriate label (For Marketed products, if applicable)

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

Ensure all cases that require expediting reporting to worldwide Regulatory Agencies or other

recipients are prioritised for processing and submission within the regulatory and/or study