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Manager Database Management & Analytics, CSPV

Basking Ridge, NJ 07920

Posted: 09/09/2024 Employment Type: Contract Job Category: Pharmacovigilance Job Number: 610629 Is job remote?: Yes Country: United States

Job Description


Target Pay Rate: 40-70/hr **salary will be commensurate with experience 

Job Description: 

  • 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
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.
  • Professional, proactive demeanor. 
Education:
BS Computer Science/equivalent qualification with at least four (4) years of experience in Pharmacovigilance 
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About Basking Ridge, NJ

Discover exciting job opportunities in the vibrant area surrounding Basking Ridge, New Jersey! Known for its picturesque landscapes, rich history, and thriving business community, Basking Ridge offers an unparalleled quality of life for professionals seeking growth and success. With easy access to NYC and iconic landmarks like the historic Jacobus Vanderveer House and the stunning Scherman Hoffman Wildlife Sanctuary, this charming region provides a perfect blend of career prospects and leisure pursuits. Indulge in locally sourced cuisine, catch a show at the elegant Ridge Performing Arts Center, or explore the natural beauty of Lord Stirling Park. Embrace the unique culture and endless possibilities that Basking Ridge has to offer as you explore our latest job listings and embark on a fulfilling career journey in this enchanting area.

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.