Manage and process all SAEs as per project specific instructions
Document Control: maintain electronic files for department, perform file case searches, maintain file room for the department and use department databases to track, manage and control issued documents; assign various tracking numbers
Track and process assigned pharmaceutical and Data Management Center (DMC) queries
Assist in the preparation of contract-required reports
Generate specified data reports from the safety database as requested
Process and edit safety narratives for IND and Non-IND Adverse Event (AE) cases as required
Distribute Safety Information according to project specific requirements
Assist in processing of MedDRA coding tasks
Perform QC on AE submissions
Job Requirements Requirements
Ability to analyze medical research data, review experimental protocols, and summarize safety data
Familiarity with medical terminology
Must have excellent attention to detail; verbal and written communication skills.
Superior organizational skills and customer service abilities are required.
Proficiency in MS Office (Word, Excel, and Outlook); experience with SharePoint is a plus.
General knowledge of the drug and vaccine development process or clinical trials is a plus.
According to the US Bureau of Labor Statistics (BLS), employment in life, physical, and social science occupations is projected to grow 5 percent from 2019 to 2029, faster than the average for all occupations, and will result in about 68,200 new jobs. Increasing demand for expertise in the sciences, particularly in occupations involved in biomedical research, psychology, energy management, and environmental protection, is projected to result in employment growth.
According to BLS, the median annual wage for life, physical, and social science occupations was $69,760 in May 2020, which was higher than the median wage for all occupations of $41,950.
Here are some occupations within Science and Research: