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Quality management EMEA and LATAM
Project duration: 7 months
Brief description
For defined countries it should be ensured that the complaint handling of Potentially Reportable Incidents (PRIs) within the EMEA LATAM organisation is carried out in accordance with the legal and global requirements of the customer.
Supplement
Within the scope of the project, the central release of Potentially Reportable Incidents (PRIs) takes place in consideration of company structures, internal and external authorities, the corresponding timelines and data quality. In the event of deviations and errors in the handling of PRIs and the avoidance and handling of Late Medical Device Reporting (MDRs) to the FDA, Complaint Handling specifications are retrained.
Subject description
Furthermore, communication to the following customer systems is ensured: International Call Center (ICC), First Level Investigation Unit (FLIU), Case Investigation Resolution Unit (CIR) and Vigilance. In addition, communication takes place with the relevant country managers as well as the local and global Salesforce support and quality teams.
Overview
- Industries pharmaceutical industry
- Specialist tasks complaints processing, Incident Management, international communication systems, KPI, quality management
- DV tasks project management
- System environment Internet/Intranet, organizational consulting, standard software: CRM systems
- Procedure model customer standard
- Standard software salesforce.com
Project period12.05.2017 - 15.12.2017
Contact
PTA GmbH Head Office
Weberstraße 2-4
D-68165 Mannheim
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