Responsibilities:
- 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
Requirements:
- B.A./B.S. Degree
- 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.
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Job Snapshot
Employee Type
Full-TimeLocation
Bethesda, MD (Onsite)Job Type
BiotechExperience
Not SpecifiedDate Posted
04/26/2023Job ID
531/192/1140