Specialist, GPV Performance Excellence (18-month FTC)

at Kyowa Kirin International plc

Marlow, UK

WE PUSH THE BOUNDARIES OF MEDICINE.

LEAPING FORWARD TO MAKE PEOPLE SMILE

At Kyowa Kirin International (KKI), our purpose is to make people smile. This means more than drug discovery and development; it is about embedding care into everything we do to make a difference every day for those that need it most. We’re an inclusive pharmaceutical company that takes time to understand what really matters to our patients, their families, and their healthcare professionals, helping our people to take bold actions that deliver life-changing solutions sooner. Our culture is rooted in our values: Teamwork, Commitment to Life, Innovation, and Integrity. They help us to push boundaries to deliver extraordinary impact and make KKI a brilliant place to work.

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.

No agencies please.