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Drug Safety Associate

Introduction

Case Analysis & Data Entry along with Mailbox-handling & Submission activities.

Function

  • To carry out pre-intake (out of database) activity. This includes safety mailbox handling and assessment of source documents for MFR receipt date, validity and country or region etc.
  • Management PV mailbox and follow-up communication as appropriate
  • Perform screening and assessment of Eudravigilance Web portal
  • Reviews full source document(s), decide on case validity and trigger requests for additional data or request of clarification,Assess seriousness of the case & accordingly prioritize
  • Performs duplicate check, register case & attach source document(s) in client’ patient safety application
  • Accurate and timely case management of serious and non-serious adverse events into patient safety application according to User Manual, SOPs and relevant data entry instructions
  • Creation of comprehensive case descriptions (narratives) in English language extracting relevant PV information from routine source documents
  • Transmission to DSUs of emails of complete cases/docs not to be inserted in client safety application (if needed)
  • Timely completion of cases routed back from the Drug Safety Scientist/ Drug Safety Physician for correction
  • Initiate follow-up activities to obtain additional information and clarification, as appropriate
  • Forward cases for quality review or invalid workflow, as applicable, in the patient safety application
  • Perform reconciliation, and document and track compliance related data
  • Requirements

    • Bachelors/Masters in Pharmacy or Graduate/Post Graduate in Life Sciences or Alternate Medicine, Biomedical Degree or Nursing etc.
    • Fluent in English
    • Basic competence with medical and therapeutic terminology
    • Able to work independently, guided by procedures, with appropriate support
    • Good time management and prioritisation
    • Attention to detail

    Advantages:

    • Prior relevant experice in Life Sciences or Health Care industry
    • Prior Experience in pharmacovigilance

    Information

    For more information, please contact Fanni Zsigri on: +36 30 160 5236

    Application

    For more information please contact Fanni Zsigri on: +36 30 160 5236