Case Documentation, High volume database management, Case analysis.
Post Market Surveillance & Vigilance activities for Class A, B, C - Analyzers & Reagent, Compliant Handling, FSCA & FSN rollout, Adverse event reporting, Safety & Risk assessment & minimization, compliance, Root cause investigation, Quality assurance, Incident reporting, PMCF, Health authority interactions, CAPA, trend analysis, PMS plan development, Cross-functional collaboration, Conducting Vigilance training for affiliates and distributors. Active correspondence with MedTech Europe regarding PMS & Vigilance Topics.
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