The position is primarily responsible for the creation and maintenance of client Pharmacovigilance System Master Files, in line with global regulations, legislation, PrimeVigilance and Client requirements.
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The position will maintain and manage PSMF for clients,
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Activities will include PSMF:
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Authoring
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Revision
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Quality check review聽
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Tracking
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Attend regular PSMF meetings with internal employees and Clients.
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May聽take responsibility in聽audits/inspections聽when scope聽is applicable聽to the PSMF聽department.聽聽
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Revision and update of PSMF related quality documents.