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PRI Approval
Project duration: 6 months
Brief description
Quality assurance and approval of Potentially Reportable Incidents (PRIs) and Quarterly Complaint Check.
Supplement
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.
Subject description
The Project is ensuring the complaint handling of Potentially Reportable Incidents (PRIs) within the organization (defined countries) in accordance with the legal and global Diabetes Care specifications, timelines and data quality.
Overview
- Industries pharmaceutical industry
- Specialist tasks Audit, GxP/GMP, international communication systems, QM in the project, quality assurance
- DV tasks project management
- System environment Cloud Computing, Internet/Intranet, organizational consulting, standard software: CRM systems
- Procedure model Waterfall Model
- Standard software salesforce.com
Project period01.01.2019 - 30.06.2019
Contact
PTA GmbH Head Office
Weberstraße 2-4
D-68165 Mannheim
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