Full-Time Clinical Safety System Administrator

Position Summary This role involves database administration within the Safety System Administrator Team. Responsibilities include database instance creation/upgrade, change control, data migration, user support, and training.

Principal Responsibilities

• Maintenance of database libraries
• System validation activities
• Database interrogation and output generation for internal/client use
• Training and access provision to internal/client users

Principle Functions for the Client

• Setup and maintenance of project-specific database libraries (products, licenses, studies, reporting destinations)
• Documentation and validation of database changes
• Support during legacy data transfers (validation)
• Guidance to Project Managers/Clients/Project Start-up Teams on data handling guidelines
• Preparation of line listings, tabulations, and other database outputs for reports, signal detection, reconciliation, etc.
• Provision of case processing metrics for invoicing (e.g., submissions, case types)
• Database training for clients
• Provision and documentation of client/internal team access

Principle Functions for the Company

• Coordination of user access (maintenance/revocation)
• Maintenance of database procedures and data handling conventions
• Database training and certification for PrimeVigilance users
• User support and troubleshooting
• Root cause investigation of database deviations and documentation of corrective actions
• Provision of case processing quality and compliance metrics to the Quality Team
• Identification of improvement areas via training, guideline clarifications, etc.
• Execution of business continuity testing for database failure
• Software bug/user request/regulatory change management and validation
• Collaboration with IT, database vendor, and technical colleagues on troubleshooting and enhancements

Other Supportive Responsibilities

• Assistance to PrimeVigilance senior management (as needed)
• Potential for chargeable consulting/training to clients on Argus and LSSMV (if required)

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