Safety Writing Assistant II

Job description : 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. Conducting operations in 100 countries, Fortrea is transforming drug and device development for partners and patients across the globe. Perform allied activities such as generation of outputs/reports from the databases or safety systems, distribution of data requests, sales data calculations, regulatory website searches, collating report planning materials, etc Author parts of various safety reports for global regulatory submissions, including but not limited to Annual Reports (IND and other), Periodic Safety Update Reports, Periodic Adverse Drug Experience Reports, Periodic Benefit-Risk Evaluation Reports, Development Safety Update Reports, Risk Management Plans, and other documents as assigned Develop the assigned report parts, examples of which may include sections with majorly pre-populated template text, re-use of content from other documents, or low to medium complexity of safety analyses Review and annotate line listings, prepare case narratives ordata summaries, and present data per approved strategy Participate in comment resolutiondiscussions for the assigned sections Support medical writers in signal detection activities, including data cleaning, review, and annotation of line listings, creating supporting material for signal review meetings, and preparing parts of signal report