Risk Management Director

hace 1 semana


Barcelona, Barcelona, España Innovative Medicines A tiempo completo
Job Summary

The Risk Management Manager plays a vital role in identifying and mitigating risks that impact the Vigilance system and the broader organization. This includes overseeing the management of Patient Safety Quality Issues and Quality Events in AQWA/1QEM.

Key Responsibilities:
  1. Receipt and Entry: Oversee the receipt of Quality Issues and Quality Events, ensuring timely entry into AQWA/1 QEM.
  2. Investigation and CAPA: Implement CAPAs and ensure the completion of effectiveness checks, timely closure in AQWA/1QEM.
  3. Actionable Insights: Drive the development of actionable insights and mitigation plans to identify and act upon opportunities for improvement.
  4. Strategic Projects: Lead and support strategic projects related to Risk Management of the Novartis Vigilance System.
  5. Guidance and Training: Prepare and maintain guidance documents and training material to educate Patient Safety associates on the Quality Issue & Quality Event process.
  6. Compliance Monitoring: Monitor compliance of the Patient Safety organization to Quality Issue & Quality Event handling processes and standards.
  7. Collaboration: Collaborate with Compliance, Process Excellence, QPPV Office, and other functions to identify areas of risk.
  8. Regulatory Compliance: Support the review of emerging worldwide regulations, performing impact assessments, and driving process changes required for ongoing compliance.

This role requires strong leadership and collaboration skills to ensure the effective management of risks and the development of strategic initiatives.



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