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Head of Risk Governance
hace 2 meses
Job Summary
As the Head of Risk Governance for Innovative Medicines, you will be responsible for establishing and maintaining a robust risk governance framework within the organization. This includes identifying and managing risks within the pharmacovigilance and medical devices vigilance system, as well as the quality management system (QMS) for the Novartis group.
About the Role
- Drive the strategy and adoption of robust risk management practices across the vigilance system, ensuring that teams are properly implementing the risk management cycle, quality issue management, and methodologies.
- Establish and maintain the risk governance framework across Innovative Medicines, in partnership with Ethics, Risk & Compliance, Quality Assurance, and other stakeholders.
- 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 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 in managing 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.
- Act as Risk & Compliance Committee officer, preparing process owners to present vigilance risks and robust mitigation plans to senior Innovative Medicines leadership, and supporting the chair with the conduct of the board.
- Lead and support strategic projects related to Risk Management and Governance of the Novartis Vigilance System.
- Lead the development and maintenance of respective processes, including ownership of relevant PSMF sections and annexes, procedural/guidance documents, and training.
- 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 the 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.
- Collaborate with other Global Line Functions across Novartis group and Third Parties to establish and meet joint accountabilities, including the non-drug risk management strategy across Development.
- 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.
