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Drug Safety Scientist

Function

  • Quality review of cases according to User Manual, SOPs and relevant data entry instructions
  • Check data entry accuracy, coding consistency and Case completeness
  • Re-evaluation and assessment of case reports for seriousness, listed ness and causality of all serious and non-serious adverse events
  • Review the narratives and check against the information from routine source documents
  • Make corrections and updates as appropriate
  • Providing timely feedback (& feedback form) to the associates based on the errors captured in mutually agreed QC checklist while reviewing & correcting the cases
  • 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
  • Submission tracking, review, distribution and reconciliation.
  • Daily screening of EV WEB for identifying any potential spontaneous cases from EudraVigilance
  • To support Clinical Trial Protocol related activities, Participate in initial, review & final discussion of a new clinical trial protocol with Project Lead
  • Ascertain protocol requirements along with other stakeholders
  • Decide AE/ SAE reporting approach which includes AE/ SAE template creation, decide & finalize of case management approach including AE/ SAE reconciliations pertaining to applicable clinical trial & communicate to the relevant stakeholders.
  • Participate in periodic & ad-hoc meetings & update calls.
  • Interact with all third party involved for all activities related to reconciliations activities
  • Training the new starters for the role as required
  • Prepare monthly & periodic reconciliation reports and presentations.

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
  • Prior relevant experience of minimum 1 year in Health Care or Life Sciences industry
  • Able to work independently, guided by procedures, with appropriate support
  • Good time management and prioritization
  • Attention to detail
  • Problem solving