Data Safety Associate
39d ago
  • Job description
  • Overall Purpose of the job

    Responsible for prioritization and creation of cases in the global safety data base, identification of duplicate cases, complete data entry accurately.

    Responsibilities / Authorities

  • Access the designated e-mail box(es) / case receipt tool
  • Create / prioritise cases based on regulatory day and reporting requirement.
  • Perform duplicate check against the safety database for all individual case safety reports to identify case reports already existing in the safety database for that patient.
  • Determine whether the case would be an initial report or a follow-up to a report already available in the database and create initial case reports as relevant.
  • Perform Medical coding in the Safety database as required.
  • Archive all source documents and correspondence mails relevant to case mails in individual case folders in the source document archiving tool.
  • Acknowledge the safety information to the sender.
  • Enter all relevant data into the safety database based on the information available in the source documents.
  • Provide a narrative for each case, which reflects the safety data and is in accordance with client Guidelines and SOPs.
  • Perform validation of the data for each case and make any corrections as needed.
  • Submit the case safety reports to subsequent step in the workflow.
  • Generate queries for missing information and inform the Medical / Scientific reviewer to validate queries.
  • Review the responses to queries when received and update the safety database as required.
  • Ensure compliance to client SOPs, conventions and guidelines for all activities performed.
  • Promote / participate, as appropriate, internal and external
  • Basic qualifications
  • Degree in Healthcare Science Preferred, minimum requirement post graduate degree in life science

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