Job Description

Job Title: Manager Database Management & Analytics, CSPV

Location: 211 Mt Airy Rd, BASKNG, Basking Ridge, NJ - office 1 day a week

Duration: 1 year

Job Schedule:

• HM greatly prefers local candidate who can come in office 1 day a week. Please note any travel-related expenses would have to be absorbed by the candidate.
• 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.
• Soft Skills: Candidate must have a professional, respectful, proactive demeanor. Able to communicate effectively and collaborate with different stakeholders and functional areas. Willing and able to provide support to other team members on projects; tasks; etc.

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