Covance

  • Drug Safety Support Specialist, Sofia

    Job Location(s) BG-Sofia
    Job Number
    2018-25461
    Job Category
    Drug Safety
    Position Type
    Full-Time
  • Job Overview

    Get ready to redefine what’s possible and discover your extraordinary potential at Covance. Here, you’ll have the opportunity to personally advance healthcare and make a difference in peoples’ lives with your bold ideas and unique point of view. With the support of exceptional people from across the globe and an energized purpose, you’ll be empowered to own your career journey with mentoring, training and personalized development planning.

    Join us as we speed the delivery of groundbreaking therapies and anticipate tomorrow’s drug development challenges, creating new possibilities for our clients—and your career.

     

    COVANCE is a leading global drug development services company and we provide support to the Pharmaceutical and Biotechnology industries. We have an exciting opportunity available to join our team.


    We are currently recruiting Drug Safety Support Specialist to join our team in Sofia, Bulgaria

    This is a 6-month fixed term contract position.

     

    Duties and Responsibilities:

    • Assist in the processing of expedited safety reports (ESRs). This includes, but is not limited to:
      • maintenance of adverse event tracking systems
      • set-up and maintenance of project files, core process files and central safety files
      • assist with the reporting of ESRs to clients, regulatory authorities, ethics committees, investigators and Covance project  personel, if required, within study specified time lines.
    • Provide administrative support to PV &DSS personnel (e.g. word processing, proof-reading and editing correspondence/documents, mailings, filing, faxing, photocopying and archiving etc)
    • Ensure all incoming faxed Serious Adverse Event (SAE) reports are appropriately stamped, logged into the departmental tracking application and forwarded in a timely manner to the designated Drug Safety Associate (DSA)/Senior Drug Safety Associate (Sr. DSA)
    • Where applicable, check the PV&DSS hotline mailbox regularly for reported SAEs and forward messages to the designated DSA/Sr. DSA.
      Assist in the maintenance of files regarding adverse event reporting requirements in all countries
    • Maintain and distribute a weekly schedule for PV&DSS staff
    • Work within the Standard Operating Procedure (SOP) system, including departmental Work Instructions (WIs)
    • Build and maintain good PV&DSS relationships across functional units
    • Ensure submission of client-related documents is sent to the client within designated timeframes (e.g. SAE reports, ESRs, Safety Management Plans (SMPs ))
    • Assist the DSA/Sr. DSA in preparation of materials needed for client and/or investigator meetings
    • Any other duties as assigned by management.

    Education / Qualifications

    • Bachelor degree education or higher

    Experience

    • Attention to detail
    • Team player
    • Solid written and verbal communication skills
    • Accurate math and spelling skills preferably with an aptitude for handling and proof-reading numerical data
    • Knowledge of MS office Windows applications
    • Ability to operate standard office equipment

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