Head of Risk Governance
hace 5 días
**Job Summary**
We are seeking a highly skilled and experienced professional to lead our Risk Governance function within the Pharmaceuticals and Vaccines (PS&PV) division of Novartis. The successful candidate will be responsible for establishing and maintaining a robust risk governance framework, identifying and managing risks within the pharmaco- and medical devices vigilance system, and ensuring compliance with regulatory requirements.
**Key Responsibilities**
- Develop and implement a comprehensive risk governance framework across PS&PV, 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.
- 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 PS&PV 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.
- Develop and maintain respective processes, including ownership of relevant PSMF sections and annexes, procedural/guidance documents, and training.
- Monitor compliance of the PS&PV organization to deviation and quality incident handling processes and standards, and develop and implement strategies to address deficiencies.
- 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 PS&PV 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.
**Requirements**
- Proven experience in risk management and governance, preferably in the pharmaceutical industry.
- Strong leadership and team management skills.
- Excellent communication and interpersonal skills.
- Ability to analyze complex data and drive business decisions.
- Strong understanding of regulatory requirements and industry standards.
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