Senior PV Quality Lead: Process & Training Excellence

F. Hoffmann-La Roche AG; Welwyn; Hybrid; GBP 65,000 - 90,000; Full time

Benefits offered by this job

Hybrid work model

Job summary

Roche Products Ltd. is seeking a Senior Pharmacovigilance Quality Specialist to lead quality activities within Pharmacovigilance and Quality Management Systems.

You will support license-to-operate activities, develop process documentation, training packages, and collaborate with Global stakeholders to ensure patient safety and regulatory compliance. The role requires involvement in GVP/GCP/MDR inspections, PV continuity, and process improvement.

Qualifications

• Experience in pharmacovigilance, clinical safety or medical device vigilance, with quality activities.
• Knowledge of regulatory requirements related to quality management systems.

Responsibilities

• Process management: develop and update procedural documentation and records to meet regulatory requirements.
• Training management: design and implement training materials and learning approaches.
• Stakeholder collaboration: build relationships with Global & Business Process Owners and Quality teams to align on quality approaches.
• Inspection readiness: support GVP/GCP/MDR safety audits and inspections, especially document requests.
• Participate in PV System Master File management, PV Compliance Monitoring, CAPAs and related processes.

Skills

Quality experience

Collaborative

Analytical

Self-motivated

Job description

Roche Products Ltd. is seeking a Senior Pharmacovigilance Quality Specialist to lead quality activities within Pharmacovigilance and Quality Management Systems.

You will support license-to-operate activities, develop process documentation, training packages, and collaborate with Global stakeholders to ensure patient safety and regulatory compliance. The role requires involvement in GVP/GCP/MDR inspections, PV continuity, and process improvement.