Risk Management Director

hace 1 semana


Madrid, Madrid, España Novartis A tiempo completo
About the Role

The Risk Management Director will lead activities and initiatives designed to identify and categorize risks that potentially impact the Vigilance system and the broader organization. This includes the preparation of action plans for leadership endorsement and oversight of the management of Patient Safety Quality Issues and Quality Events in AQWA/1QEM.

Key Responsibilities:
  • Receipt and Management of Quality Issues and Quality Events
  • Entry and Timely Completion of Investigations
  • Implementation of Corrective Actions and Availability of Evidence
  • Completion of Effectiveness Checks and Timely Closure
  • Development of Actionable Insights and Mitigation Plans
  • Leadership of Strategic Projects Related to Risk Management
  • Preparation and Maintenance of Guidance Documents and Training Material
  • Monitoring of Compliance with Quality Issue and Quality Event Handling Processes
  • Collaboration with Compliance, Process Excellence, and Other Functions
  • Development and Maintenance of Procedural Documents
  • Support of Emerging Worldwide Regulations and Regulatory Compliance
  • Subject Matter Expertise during Audits and Inspections
  • Preparation of Reports and Presentations
Requirements:
  • Minimum 4 years of experience in the pharmaceutical industry, particularly pharmacovigilance
  • Experience in project management and demonstrated ability to lead work groups
  • Ability to deal and interact with a wide variety of people at all levels
  • Strong negotiation, presentation, and communication skills
  • Excellent analytical skills
  • Ability to mentor and coach
  • Educational Background: PharmD, MSc Degree in Life Sciences or equivalent

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