Job Summary

A contract research organization is in need of a Telecommute Senior Safety Surveillance Associate.

Must be able to:

• Review and analyzes safety report information for completeness, accuracy and regulatory reportability requirements
• Prepare safety reports, including preparation of narrative summary within specified project, regulatory, and/or key performance indicator timelines
• Perform all tasks consistent with department controlled documents and department guidance

Required Skills:

• Bachelor’s degree in nursing or equivalent combination of education and experience
• 5+ years safety surveillance experience
• Advanced knowledge of medical terminology and of GCPs, ICH guidelines, FDA and other applicable country regulations
• Advanced proficiency in Microsoft Word, Excel, and PowerPoint, Outlook
• Knowledge of Safety database software and related software functionality