Career Category
Engineering
Job Description
Group Purpose:
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
Participate in the implementation of routine system configuration including reporting rule updates, product and study configuration
Augment and/or define search strategies in collaboration with leads to ensure consistent data outputs
Support study startup activities such as RAVE-Argus mapping User Acceptance Testing (UAT), Mapping Specifications Worksheet (MSW) approval
Participate in user UAT of safety system changes
Contribute to the development and maintenance of technical solutions to support safety system and data outputs
Participate in the development and delivery of training related to safety database and tools
Assist in the development of system support related quick reference guides.
Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness
Support Authority Inspection and Internal Process Audits within the remit of role and responsibility
Knowledge and Skills