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Senior Good Clinical Practices -Pharmacovigilance (Xico)

Company

Link-Worldwide

Location

estado de méxico, estado de méxico

Type

Full-time

Senior Good Clinical Practices - Pharmacovigilance Auditor – MexicoHybrid role.OverviewLead, support and report independent GCP/PV audits according to the NVS Quality System and current GCP/PV regulations to assess compliance with applicable regulations, standards, and documents.Review and approve corrective action plans in support of audit observations.Main ResponsibilitiesSupport the strategic development of an effective global risk‐based audit strategy and programme; collect, collate and incorporate input into audit strategy and plan.Lead, plan, conduct, document and follow‐up integral quality regulatory compliance audits and assessments of GCP/GxP according to the requirements specified in the respective Novartis Quality Module and applicable regulations, standards, quality agreements, and documents.Perform activities with a high degree of independence.Assess adequacy of responses (CAPA plans) to audit findings in agreement with Follow‐up Responsible Person and Quality Responsib...

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