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Job Title: Adverse Experience Reporting Coordinator - III
Category:  Professional & Business Operations
Performs those activities essential to the management of Individual Case Safety reports (ICSRs) to ensure reports are processed in an accurate and timely fashion in accordance with regulatory requirements. On a continual basis actively works to promote operational excellence by monitoring and improving processes related to adverse experience management.

Primacy Activities include but are not limited to:
  • Provide content for the ongoing development and maintenance of the Global Safety Database User Manual, Standard Operating Procedures, and training material.
  • Perform activities related to entry of individual adverse experience reports into the Global Safety Database (MARRS)
  • Provide support and training in topics related to Individual Case Safety reports (ICSRs) and other tasks for team members of assigned projects as required.
  • Perform quality review checks on the entry and management of ICSRs to ensure adherence to global case processing standards and regulatory requirements.
  • Perform compliance monitoring activities for expedited individual case submissions to regulatory agencies worldwide.
  • Initiate communication of appropriate actions to address quality and compliance concerns. 
Bachelor's degree, preferably in a biological science, nursing, or pharmacy. At least one year of experience in a hospital, pharmaceutical or research position. 
Location  West Point , PA
Minimum Experience (yrs):  1+
Required Education:  Not Specified

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