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.