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Drug Safety Associate

Function

  • Safety Mailbox management includes track of incoming SAE forms, tracking, Evaluation and follow-up communication as appropriate
  • Manage incoming source document, perform validity assessment, duplicate check and register cases to safety application
  • Accurate and timely data entry of serious and non-serious adverse events into patient safety application according to User Manual, SOPs and relevant data entry instructions
  • Perform case assessment, medical coding and labelling based the product reference safety information.
  • 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
  • Electronic (E2B) and manual submission of reports to regulatory authorities according to national legal requirements and to business partners as per Safety Data Exchange Agreement (SDEA)
  • Interaction with different groups from customer’s end for exchange of safety information in defined format
  • Training the new starters as required
  • Liaise with support desk and/or case processing team
  • Perform reconciliation, and document and track compliance related data. Reconciliation activity includes maintenance of records pertaining to number of cases for submission & submission status with date & time within specific intervals

Requirements

  • Bachelors/Masters in Pharmacy or Graduate/Post Graduate in Life Sciences or Alternate Medicine, Biomedical Degree or Nursing etc.
  • Basic competence with medical and therapeutic terminology
  • Advantages:
  • Prior relevant experience in Life Sciences or Health Care industry
  • Prior Experience in pharmaco vigilance
  • Other requirements:

  • Able to work independently, guided by procedures, with appropriate support

  • Good time management and prioritisation

  • Attention to detail