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Konkurs je istekao.

Database Superuser Associate

PrimeVigilance d.o.o.

Beograd

25.01.2018.

ugovor puno radno vreme

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PrimeVigilance is a dedicated pharmacovigilance, regulatory and medical information service provider with offices in UK, US and Europe. PrimeVigilance supports pharma, biotech and generics companies in managing the global safety of their products from early clinical trial development through to full post-marketing activities. PrimeVigilance has now over 400 in house employees plus a network of EEA & Domestic QPPVs.

  • Full drug safety pharmacovigilance, regulatory and medical information services
  • Global reach
  • Access to regulatory experts and key opinion leaders
  • Inspections Ready
  • Tailored approach to partnering
  • Transparent and competitive pricing models and invoicing
  • Full range of specialist consulting services

We are looking for:

Database Superuser Associate

Belgrade

Key Accountabilities

For the Client

    • Set up and maintenance of project specific database libraries including:
    • Company Product Library
    • Person Library
    • Distribution / Submission Library
    • Company Units Library
    • Protocol Library
    • Documenting and validating any change to the project specific database
    • Support during legacy data transfer e.g., validation
    • Supporting/providing guidance to the Project Manager / Client / Project Start Up Team during the development of project specific data handling guidelines (to ensure project specific guidelines are necessary and will not impact line listings and report generation)
    • Prepare line listings and tabulations and other database outputs for use in aggregate reports, signal detection, reconciliation and other activities as required
    • Provide case processing metrics required for invoicing (e.g., number of submissions, number of spontaneous vs initial cases processed)
    • Provide database training to clients
    • Providing and documenting client / internal team access upon receipt of an approved access request
    • Development and validation of client specific ad hoc report requests via Business Objects

For the Company

    • Coordinate user access (including role maintenance and revoking access)
    • Maintain database procedures including core data handling conventions
    • Provide database training and certification to PrimeVigilance users
    • Provide user support
    • Lead root cause investigation of database related deviations and ensure timely and complete documentation of resulting actions in line with CAPA procedures
    • Provide case processing quality and compliance metrics to the Quality Team
    • Identify areas for improvement and address via training, clarifying changes to data handling guidelines, user guides etc.
    • Prepare internal reports (ad hoc metrics reports e.g., average case processing time, cases data entered within a given time period etc.,) for use by Case Workflow Managers, Director of Projects, Director Resourcing and Planning, Business Development Director, Director of PV and MI Operations and other senior stakeholders
    • Execute business continuity periodic testing for database failure
    • Ensure that existing software bugs, user requests, changes to regulatory requirements etc., are considered and appropriate changes are made and validated as required
    • Support IT, database vendor and technical colleagues in troubleshooting and implementing software fixes and enhancements as required

Qualifications and Skills

  • Educated to degree standard or appropriate equivalent work experience
  • Previous experience with technology troubleshooting
  • Experience in the administration and maintenance of infrastructure, software and systems
  • Strong proficiency in Database Management
  • Has knowledge of commonly used concepts, practices, and procedures including inventory control and configuration
  • Excellent communications skills with fluent command of English (written and oral)

Our Offer

  • Competitive salary
  • Work within a successful, highly – qualified and dynamic team
  • Professional training and career development in a fast growing healthcare company

Deadline for applications: 25.01.2018.

    Konkurs je istekao.

    PrimeVigilance d.o.o.

    • Đorđa Stanojevića 14, Beograd, Srbija
    • PIB: 109436311
    • Matični broj: 21181986
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