Regional Pharmacovigilance Quality Leader

Novartis UK; Greater London; Presencial; GBP 64 000 - 119 000; Tempo integral

Resumo da oferta

Novartis UK in London is seeking a Senior PV QA professional to oversee regional and country vigilance quality systems, CAPAs and inspections, ensuring compliance with global PV regulations.

You will partner with PS & PV teams, drive quality improvements, support CAPA plans, and prepare for Health Authority inspections. A Life Sciences degree and PV/QA experience are required, with strong English communication.

Qualificações

• Degree in Life Sciences or related discipline; higher degree desirable.
• Excellent written and verbal English communication skills; fluency in a second language a plus.
• Quality/PV/clinical/regulatory affairs/pharmaceutical industry experience; GCP/PV/GMP auditing or health authority interactions a plus.

Responsabilidades

• Oversee regional and country vigilance quality systems and CAPAs across PV; ensure regulatory compliance.
• Coordinate with PS and PV teams to monitor PV system performance against global, regional, and country regulations.
• Support Global PV QA in executing Quality Risk Assessments and maintaining the Pharmacovigilance System Master File (PSMF).
• Lead preparation for HA vigilance inspections; review inspection CAPA plans and ensure evidence is robust and sustainable.
• Identify regional training needs and deliver knowledge-sharing sessions to improve PV quality and compliance.
• Provide guidance on M&A and divestment relevant activities affecting the vigilance system.

Conhecimentos

English communication

Quality mindset

Problem solving

Team leadership

Formação académica

Life Sciences degree

Descrição da oferta de emprego

Novartis UK in London is seeking a Senior PV QA professional to oversee regional and country vigilance quality systems, CAPAs and inspections, ensuring compliance with global PV regulations.

You will partner with PS & PV teams, drive quality improvements, support CAPA plans, and prepare for Health Authority inspections. A Life Sciences degree and PV/QA experience are required, with strong English communication.