Summary
Responsible for establishing and maintaining the risk governance framework within PS&PV including identification & management of risks within the pharmaco- and medical devices vigilance system & PV Quality Management System (QMS) for Novartis group. It includes escalating risks to senior PS&PV leadership and overseeing the development and implementation of appropriate remediation plans at Corporate level to protect Novartis reputation.
About the Role
Drive the strategy and adoption of robust risk management practices across the Vigilance System; oversee that teams are properly implementing the risk management cycle, quality issue management and methodologies and adhere to Novartis Corporate Standards.
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, their respective mitigation plans and trending.
Benchmark risk governance standards across the industry, review emerging worldwide regulations, performing global impact assessments, and driving 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.
Lead the development and maintenance of respective processes including ownership of relevant PSMF sections and annexes, procedural/guidance documents & 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.
Acts 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
Education
PharmD, MSc degree in life sciences or equivalent.
Languages
Fluency in English. Knowledge of other languages desirable.
Professional requirement
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 of advantage
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
A strong communicator with the ability to deal and interact with a wide variety of people at all levels.
Quality focus
Strong analytical/investigative skills
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