Covance

  • Safety Science Analyst

    Job Location(s) IN-Bangalore
    Job Number
    2018-20635
    Job Category
    Clinical Operations
    Position Type
    Full-Time
  • Job Overview

    • 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 personnel, if required, within study specified timelines.
    • 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

    Required:

    Educated to at least GCSE level or equivalent.

    H.S. diploma or equivalent, some college preferred.

    Experience

    • 2 years of office 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 beneficial.

    Ability to operate standard office equipment.

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