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.