Global Pharmacovigilance QA Excellence Lead

EPM Scientific; Cataluña; Presencial; EUR 120.000 - 150.000; Jornada completa

Descripción de la vacante

EPM Scientific is partnered with a global pharmaceutical company seeking a GVP Quality Assurance Senior Manager to support the Global Pharmacovigilance and Quality function. This role focuses on maintaining and enhancing the Pharmacovigilance Quality Management System, ensuring global regulatory compliance and inspection readiness.

You will lead risk-based audit programmes, oversee GVP audits, support regulatory inspections, and drive continuous quality improvement across drug safety processes

Formación

• Extensive experience in Pharmacovigilance Quality Assurance within pharma/biotech environments.
• Strong knowledge of EU GVP requirements and global pharmacovigilance regulations.
• Experience planning, conducting, managing, or overseeing GVP audits and inspection readiness programmes.
• Excellent stakeholder management and communication in global cross-functional settings.
• Proven analytical and problem-solving abilities with proactive quality/compliance focus.

Responsabilidades

• Maintain, develop, and improve the Global Pharmacovigilance Quality Management System.
• Develop and execute risk-based pharmacovigilance audit programmes across affiliates, vendors, and partners.
• Coordinate outsourced GVP audits and manage findings through to closure.
• Lead inspection readiness activities and support inspections and mock audits.
• Review and approve pharmacovigilance procedures and quality documents to ensure compliance.

Conocimientos

Pharmacovigilance QA

GVP regulations

Audit management

Stakeholder management

Analytical skills

QA training

Educación

Pharmacy or related sciences degree

Descripción del empleo

EPM Scientific is partnered with a global pharmaceutical company seeking a GVP Quality Assurance Senior Manager to support the Global Pharmacovigilance and Quality function. This role focuses on maintaining and enhancing the Pharmacovigilance Quality Management System, ensuring global regulatory compliance and inspection readiness.

You will lead risk-based audit programmes, oversee GVP audits, support regulatory inspections, and drive continuous quality improvement across drug safety processes