This group supports pharmacovigilance activities through the maintenance, development and continuous improvement of the global safety system and the provisioning of high-quality data outputs/visualizations.
Job Summary:
Support changes to the global safety system and associated Datamart
Support the implementation of global safety system configurations
Support accurate clinical trial safety data collection in the global safety system
Key Activities:
With limited direction from Sr. Manager-Safety Data Analyst (SDA), the Sr. Associate - SDA may perform the following activities:
Generate outputs from the global safety system in support of
periodic safety reports (e.g., PADER, PSUR, DSUR)
signal detection
audits, inspections and regulatory inquires
Ensure delivery of automated/scheduled safety data outputs
Perform Quality Checks/Peer Review as needed for data outputs and routine system configurations
Participate in collecting business requirements for routine safety data outputs
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