Fortrea is a leading global contract research organization (CRO) with extensive expertise in clinical development. With operations spanning across approximately 100 countries, Fortrea is dedicated to transforming drug and device development for pharmaceutical, biotechnology, and medical device customers. Our commitment to scientific rigor and decades of experience enable us to provide innovative clinical development, patient access, and technology solutions across more than 20 therapeutic areas. If you’re passionate about making a meaningful impact in global health, Fortrea is the ideal place for you.
Job Description:
As a Safety Writing Assistant II, your primary responsibilities will include:
- Data Management: Perform allied activities such as generating outputs/reports from databases or safety systems, distributing data requests, calculating sales data, conducting regulatory website searches, and collating report planning materials.
- Report Authoring: Author sections of various safety reports required for global regulatory submissions. This includes but is 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.
- Content Development: Develop the assigned report parts, which may involve utilizing pre-populated template text and reusing content from other documents. Engage in data analyses of low to medium complexity, review and annotate line listings, prepare case narratives or data summaries, and present data per approved strategies.
- Collaboration: Support medical writers during signal detection activities by cleaning data, reviewing and annotating line listings, creating materials for signal review meetings, and preparing specific sections of signal reports.
Why Join Fortrea?
Fortrea is searching for motivated problem-solvers and creative thinkers who are passionate about overcoming barriers in clinical trials. We offer a collaborative workspace that fosters personal growth, allowing you to make a significant global impact. Our commitment to revolutionizing the development process ensures that life-changing therapies reach patients swiftly.
