Category

Drug Safety

Job Type

Full-Time

Education

Bachelor's Degree

Travel

None

Job Description

• 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

• 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.

We are equal opportunity/affirmative action employers, committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status, or any other protected characteristic under state or local law.