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Approval of Potentially Reportable Incidents (PRIs)
Project duration: 3 months
Brief description
Quality assurance and approval of Potentially Reportable Incidents (PRIs) and Quarterly Complaint Check.
Subject description
Ensuring the complaint handling of Potentially Reportable Incidents (PRIs) within the EMEA LATAM organization (defined countries) in accordance with the legal and global Diabetes Care specifications, timelines and data quality. Central release of PRIs and correspondence with relevant interfaces: ICC, First Level Investigation Unit (FLIU), Case Investigation and Resolution Unit (CIR), Vigilance, the responsible countries, local and global Salesforce support and quality teams.
IT project data
- Industries pharmaceutical industry
- Specialist tasks CAPA, international communication systems, ISO 13485, KPI, quality management, Regulatory affairs
- DP tasks project management
- System environments Cloud Computing, Internet/Intranet, organizational consulting, standard software: CRM systems
- Procedure model Waterfall Model
- Standard software and BI Salesforce
Project period19.01.2018 - 30.04.2018
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