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Pharmacovigilance Auditor Training

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  • Deepak
    26/09/2019 11:51
    Hello, Do Pharmacovigilance QA auditor need to get trained on all pharmacovigilance SOPs (for e.g. PSUR preparation, ICSR processing) during their induction training program in new organization? Also, when a Pharmacovigilance SOP get revised; do the QA auditor need to be get trained?
  • Manoj Swaminathan
    30/09/2019 21:07
    In simplest terms, the answer to your question(s) is 'No'. However all of these depend on how integrated the PhVQA in your organization is. If PhVQA reports to the head of Global Safety, then he/she may expect that PhVQA is trained on all SOPs/WIs. If PhVQA has an independent reporting, then it may not be necessary to be trained on the PhV SOPs/WIs unless the PhVQA is one of the reviewers of the PhV documents including SOPs/WIs. All in all, it is ideal to have an embedded PhV system with PhVQA supporting the functions on a daily basis.
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