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Drug Safety Physician

Function

  • Perform triage during case intake activity
  • · Medical review and Quality review of cases according to User Manual, SOPs and relevant data entry instructions

    · Medical evaluation of case by performing event assessment, checking the seriousness, labeling & causality assessment

    • Confirmation of the accuracy of medical coding of all AE/ SAE and medical cohesiveness of the narrative
    • Authors the company causality/case comment (CCC)
    • Determination of additional actions required such as additional query to reporter
    • Provide medical questions to be included in follow-up attempts
    • Support the case processing team for any queries
    • 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

  • Medical Doctor (MD) or Board certified Physicians or higher degree etc.
  • Basic competence with medical and therapeutic terminology
  • Able to work independently, guided by procedures, with appropriate support
  • Decisive & problem solving
  • Good time management and prioritisation
  • Attention to detail