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
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Tracking
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Attend regular PSMF meetings with internal employees and Clients.
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May take responsibility in audits/inspections when scope is applicable to the PSMF department.
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Revision and update of PSMF related quality documents.