Database Management Specialist
4 weeks ago
Database Management Specialist, CSPV
Job Schedule:
This role can be performed 100% remotely, with occasional on-site visits (approximately once a quarter, for a couple of days). The candidate should be based in the Northeast region. Any travel-related expenses will be the responsibility of the candidate.
This role assists in the implementation of project-specific safety database configurations to meet the regulatory and business needs of the CSPV department.
Participates in system validation activities for the safety database and other safety-related systems.
Performs quality checks on configuration changes performed by the database service provider; identifies discrepancies between the request and the implementation and resolves or initiates their resolution.
Serves as a system administrator and performs configurations/master data updates like code lists, user access, reporting rules, product, and study.
Works with the CSPV Team(s) and DBMA team to complete the configuration forms and coordinates with the Safety system service provider to complete the needed configurations.
Maintains best practices for safety database configurations, customizations, aggregate reporting, data migration, data integration, E2B Gateway reporting set-up, interface with EDC and other new automation initiatives.
Assists with data management of safety-related PV systems.
Other duties as assigned.
Must be available to work during US Business Hours.
Experience supporting Oracle Argus Safety is required.
Experience in safety reporting applications is required. Knowledge of PV reports would be helpful.
Relational database (Argus Safety database) knowledge working with Oracle and SQL is required.
General knowledge of Electronic Data Interchange (Axway B2Bi Interchange in particular a plus), Rave Safety Gateway, E2b Pilot Test with HA.
General knowledge about the global safety reporting requirements and ICH E2B guidelines that govern the international reporting of adverse events on investigational and marketed products are preferred.
Professional, proactive demeanor.
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