Regional Head, Pharmacovigilance Quality (PVQA)

Overview

In this role you lead regional and country quality oversight of the Novartis Vigilance System, ensuring regulatory compliance and robust quality practices across PV activities. You will collaborate with country teams, PS & PV, and global QA to drive the vigilance quality plan, risk assessment, CAPA governance, and inspection readiness. Your work supports safe product risk-benefit profiles and continuous quality improvements across regions. This position combines strategic guidance, cross-functional collaboration, and hands-on QA leadership to sustain high standards in pharmacovigilance.

Pay / Benefits

• hybrid working options
• base salary with potential performance bonus
• insurance plans
• retirement plans
• wellbeing resources
• global recognition programs

Responsibilities

• Lead regional quality oversight for Vigilance System implementation and maintenance by local teams, focusing on Quality Issue, proactive risk assessment and action management
• Ensure regional and country PV tasks comply with global, regional and local PV regulations and safety requirements
• Coordinate and execute the Global Vigilance Quality Plan (QP) in alignment with regional activities and report status to Global PV QA
• Monitor regional quality performance indicators and communicate risks with recommendations for mitigation
• Act as quality champion, escalating compliance issues to Global PS&PV and PV QA management, proposing quality improvements
• Lead regional quality improvement initiatives and provide governance for projects in scope
• Support PV QA team in Quality Risk Assessments (QRA) and risk mitigation for country PV systems
• Assist in maintaining the global Pharmacovigilance System Master File (PSMF) as applicable
• Maintain vigilance inspection readiness; prepare for and support Health Authority inspections and CAPA reviews in QMS
• Provide expertise on Quality Issue investigations and CAPA remediation, ensuring timely escalation and closure
• Oversee regional self-assessment planning and execution for pharmacovigilance processes; review action plans in QMS
• Identify and address training needs; deliver knowledge sharing to improve quality and compliance
• Advise on Merger & Acquisition activities related to vigilance system integration/disintegration when applicable
• Lead or support due diligence activities for potential product or company acquisitions

Key requirements

• Degree in Life Sciences or related scientific discipline
• Excellent written and verbal English; second language is a plus
• Quality/PV/clinical/regulatory affairs/pharma experience; auditing/inspection experience and HA interactions are a plus
• PV experience in country and global quality support to country stakeholders is a plus
• Ability to travel up to 20%
• Ability to independently manage and evaluate complex compliance issues with minimal supervision; strong problem solving and prioritization skills
• Quality mindset with leadership and facilitation capabilities
• Extensive knowledge of PV regulations, guidelines and policies; awareness of GCP and Part 11
• Ability to lead teams in diverse cultural environments
• Ability to deputize for Global Head PV QA Regions and Countries as needed

• Leadership
• Communication
• Problem solving
• Vigilance Quality Systems (QMS)
• Quality Management and Quality Assurance (QA)
• Regulatory compliance in PV (GVP, MDR/IVDR where applicable)

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