Drug Safety Associate

South San Francisco, CA 94080

Posted: 03/25/2019 Employment Type: Contract-to-Hire Industry: Clinical & Scientific Job Number: 15380

Drug Safety Associate


This is for a 3-6 months contract with a possibility to be a contract-to-hire opportunity.


  • Triages and maintains the Drug Safety box
  • Updates and distributes list of pending cases to Safety team
  • Updates and maintains the SAE tracker
  • Updates and maintains the Case description tracker for medical monitors
  • Maintains the Drug Safety folder in the shared drive
  • Assists in preparing the monthly SAE listing for distribution to the DMC
  • Serves as first level of Quality Control for draft case narratives and queries prior to sending to Drug Safety Manager (DSM) for second QC
  • Sends notification receipt emails to Parexel
  • Assists the DSM in maintaining Issues log with vendors, etc.
  • Assists in preparing ad hoc reports
  • Sends the BLINDED MedWatch  report to CK Regulatory (all reports) and DMC (Initials only) after DSM’ s review and approval


Job Requirements
  • Degree in life sciences. Health care professional (pharmacy, nursing or equivalent) is strongly preferred
  • 3 to 5 years of experience in drug safety is strongly preferred
  • Knowledge of adverse event regulatory reporting requirements
  • Experience with drug safety databases, case processing and MedDRA coding concepts
  • Attention to quality focusing on details with enthusiasm toward ways to improve processes
  • Demonstrated ability to work effectively, collaboratively under minimal supervision with a sense of urgency in a dynamic, cross-function matrix environment
  • Ability to solve complex problems and set priorities to complete work
  • Proficiency in the use of relevant computer systems including MS Word, Excel, PowerPoint, and Outlook
  • Safety data base knowledge preferred
  • Strong interpersonal, written and oral communication skills and professionalism



Jesse Ashworth

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