Head of Risk Governance

hace 6 días

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

As the Head of Risk Governance, you will be responsible for establishing and maintaining a robust risk governance framework within the Pharmaceutical and Vaccine Division (PS&PV) of Novartis. 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.

Key Responsibilities
  • Escalate risks to senior PS&PV leadership and oversee the development and implementation of remediation plans to protect Novartis' reputation.
  • Drive the strategy and adoption of robust risk management practices across the vigilance system, ensuring teams are properly implementing the risk management cycle, quality issue management, and methodologies.
  • Establish and maintain the 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, mitigation plans, and trending.
  • Benchmark risk governance standards across the industry, review emerging worldwide regulations, perform global impact assessments, and drive global process changes to ensure ongoing compliance with 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.
  • 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 PS&PV organization to deviation and quality incident handling processes and standards, and develop and implement strategies to address deficiencies.
  • Collaborate with the Compliance, Process Excellence, QPPV Office, and other functions to produce metrics and complete trend analyses 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.
  • Recruit and develop talents and retain high-performing associates, set up regular performance evaluations, development, and succession planning.
  • Support the Head of Compliance & Risk Management to determine OPEX strategy and set OPEX objectives.
  • Deputize for the Head of Compliance & Risk Management and the PS&PV Quality System Owner as needed.
Requirements
  • PharmD, MSc degree in life sciences or equivalent.
  • Fluency in English; knowledge of other languages desirable.
  • Minimum 7 years of experience in the pharmaceutical industry, particularly pharmacovigilance, with advanced knowledge of pharmacovigilance regulations.
  • At least 2 years of leadership/project management experience.
  • Quality assurance experience advantageous.
  • Ability to lead and deliver cross-functional initiatives in a matrix environment.
  • Strong organizational and project management skills.
  • Strong negotiation and ability to operate effectively in an international, matrix environment.
  • Strong communicator with the ability to deal and interact with a wide variety of people at all levels.
  • Quality focus.

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