Safety and Pharmacovigilance Associate at Technical Resources International

Posted in Other 26 days ago.

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Location: Bethesda, Maryland





Job Description:
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


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.
  • B.A./B.S. Degree



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