Assists the Clinical Safety and Risk Management team in the safety surveillance of assigned products. -Assists with data retrieval, data preparation, and analysis for, and quality assurance of, prepared responses to inquiries from health professionals, regulatory agencies and other customers regarding adverse experiences (AEs).
This includes contributing to the authoring of regulatory documents. -With guidance from the CSRM Associate, assists with the safety surveillance review of safety data such as adverse experience reports.
This is a Scientist position. -Bachelor’s degree required in nursing, pharmacy or other relevant health field plus 2 years of experience in clinical, pharmaceutical industry, or related field.
This position requires excellent writing and verbal communication skills, problem solving ability, and analytical skills.
Proficiency with Microsoft program package (Word, Excel, and Powerpoint) is required with data management, quality assurance, and compliance experience highly desirable -Previously authored PSURs, DSURs, or RMPs.
Any experience in drug safety is a plus