Specialist, GPV Performance Excellence

Specialist, GPV Performance Excellence (18-month FTC)

Location: Marlow, UK

Job Purpose

Kyowa Kirin is seeking a motivated Specialist, GPV Performance Excellence to join our Global Pharmacovigilance team. In this role, you will support the continuous improvement of our PV Quality Management System by contributing to audit readiness, managing deviations and CAPAs, maintaining compliance metrics, and supporting PSMF updates. This is an excellent opportunity for someone with experience in pharmacovigilance or quality assurance who is looking to advance their career in a collaborative, high‑performing environment.

Key Responsibilities

• Support the management of deviations, stand‑alone CAPAs, and related quality records in the eQMS
• Assist with PV audit activities, including audit readiness training and CAPA action tracking
• Maintain and prepare GPVPE compliance metrics
• Contribute to updates of PSMF modules and annexes, working closely with SMEs and cross‑functional partners
• Review and edit GPV procedures to ensure compliance and accuracy
• Provide administrative support for audit scheduling and document coordination
• Ensure accurate document management and record‑keeping in line with company and regulatory requirements

Position Requirements

• Bachelor’s degree in a life sciences discipline
• Strong experience in pharmacovigilance or quality assurance within pharma/biotech
• Good understanding of GVP and ICH guidelines
• Strong Microsoft Office skills (Word, Excel, PowerPoint, SharePoint, Teams)
• Excellent communication, organisation, and problem‑solving abilities
• Able to work independently, prioritize effectively, and manage multiple tasks
• High attention to detail and a proactive, flexible mindset

Kyowa Kirin International is an equal opportunities employer.

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