Head of Risk Management
hace 22 horas
Job Summary: We are seeking a seasoned professional to lead our Risk Management function within Innovative Medicines. As the Head of Risk Management, you will be responsible for establishing and maintaining a robust risk governance framework, identifying and managing risks within our Vigilance System and Quality Management System.
About the Role:
- Develop and Implement Risk Management Strategies: Drive the adoption of robust risk management practices across our Vigilance System, ensuring teams are properly implementing the risk management cycle, quality issue management, and methodologies.
- Establish Risk Governance Framework: Collaborate with Ethics, Risk & Compliance, Quality Assurance, and other stakeholders to establish and maintain a risk governance framework across Innovative Medicines.
- Lead Risk Management Team: Lead a team of Vigilance Risk Management Managers, Experts, and Associates responsible for PV system risk management and oversight of identified risks, their respective mitigation plans, and trending.
- Benchmark Industry Standards: Benchmark risk governance standards across the industry, review emerging worldwide regulations, perform global impact assessments, and drive global process changes required to ensure ongoing compliance to global regulatory requirements.
- Monitor and Analyze Risks: Proactively monitor risks for trends and patterns, drive lessons learned, and collaborate with stakeholders across Development and at Enterprise level to lead the delivery of sustainable and effective action plans.
- Support Risk & Compliance Committee: Act as Risk & Compliance Committee officer, preparing process owners to present vigilance risks and robust mitigation plans to senior leadership, and supporting the chair with the conduct of the board.
- Lead Strategic Projects: Lead and support strategic projects related to Risk Management and Governance of the Novartis Vigilance System.
- Develop and Maintain Processes: Lead the development and maintenance of respective processes, including ownership of relevant PSMF sections and annexes, procedural/guidance documents, and training.
- Monitor Compliance: Monitor compliance of the Innovative Medicines organization to deviation and quality incident handling processes and standards, and where deficiencies are identified, develop and implement strategies to address these.
- Collaborate with Functions: Collaborate with Compliance, Process Excellence, QPPV Office, and other functions to produce metrics and complete trend analyses designed to identify areas of risk with impact on the Vigilance System and/or Innovative Medicines organization.
- Support Audits and Inspections: Act as the subject matter expert on vigilance risk management during audits and inspections, lead the preparation of responses to findings in scope of assigned responsibilities, and ensure appropriate CAPAs are developed, implemented, and effectiveness verified.
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