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Monitors CSR’s performance on a daily basis, by taping, listening to, reviewing and evaluating calls...

• Support and assist PDRL colleagues to accomplish tasks in meeting deadlines
• Gradually assume responsibility for agreed tasks under supervised coaching and tutoring
• Prepare regulatory labeling packages in collaboration with other teams

• Leading and scaling PV Regional Center operations across EEMEA region
• Overseeing all PV and Device Vigilance operations in the region
• Driving absolute compliance and operational agility
• Integrating clinical safety into operations
• Directing and motivating a multi-site regional team

• Support complex and higher exposure quality and compliance activities
• Provide guidance and risk assessment on GCP, GVP, MDR, and IVDR compliance issues
• Serve as advisor and subject matter expert for quality and compliance-related processes
• Lead deviation management and process management activities

• Creating, owning and implementing a holistic change management strategy
• Driving behavioral change and technology adoption
• Actively monitoring the adoption of technical functionalities
• Identifying opportunities to enhance product usability and platform capabilities