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Manager Database Management & Analytics, CSPV

Basking Ridge, NJ 07920

Posted: 10/04/2023 Employment Type: Contract Job Category: Database Management & Business Intelligence Job Number: 587075 Is job remote?: Yes Country: United States

Job Description

Pay is commiserate with experience and ranges from $40-60/hr
  • 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.
  • Perform quality checks on configuration changes performed by the database service provider; Identify discrepancies between the request and the implementation and resolve or initiate their resolution.
  • Serve as a system administrator and perform configurations/master data updates like code lists, user access, reporting rules, product, and study, pilot tests with E2b partners in Development environment.
  • Work with CSPV Team(s) and DBMA team to complete the configuration forms and coordinate with the Safety system service provider to complete the needed configurations.
  • Maintain 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. 
  • BS Computer Science/equivalent qualification with at least four (4) years of experience in Pharmacovigilance 
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