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Manager Database Management & Analytics, CSPV
Manager Database Management & Analytics, CSPVPlanet Pharma • Basking Ridge, NJ, US
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Manager Database Management & Analytics, CSPV

Manager Database Management & Analytics, CSPV

Planet Pharma • Basking Ridge, NJ, US
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  • serp_jobs.job_card.full_time
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2 days ago Be among the first 25 applicants

  • 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.

Skills

  • 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.

    • Education

    BS Computer Science / equivalent qualification with at least four (4) years of experience in Pharmacovigilance

    Pay Rate : $40-70 / Hr

  • Salary will be commensurate with candidate experience

    • J-18808-Ljbffr

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    Database Manager • Basking Ridge, NJ, US

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