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Head of Risk Governance

hace 2 meses

Barcelona, Barcelona, España Novartis A tiempo completo

**Job Summary**

We are seeking a highly skilled and experienced professional to lead our Risk Governance function within the Pharmaceutical and Vaccine (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 Vigilance System and Quality Management System (QMS).

**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 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 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 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 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 a pharmaceutical or medical device industry.
  • Strong leadership and team management skills, with the ability to motivate and develop a high-performing team.
  • Excellent communication and interpersonal skills, with the ability to build strong relationships with stakeholders at all levels.
  • Strong analytical and problem-solving skills, with the ability to identify and mitigate risks.
  • Ability to work in a fast-paced environment, with multiple priorities and deadlines.
  • Strong knowledge of regulatory requirements and industry standards, with the ability to stay up-to-date with emerging trends and developments.