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 Specialist, GPV Performance Excellence to join the GPV Performance Excellence Monitoring team. This role plays a key part in ensuring that pharmacovigilance regulatory intelligence is identified, assessed, actioned, and tracked in line with global regulatory requirements. You will work closely with subject matter experts and cross‑functional stakeholders to support regulatory intelligence activities, monitor implementation of changes, and ensure accurate documentation, maintain the list of GPV Vendors or any vendor governance activities, and metrics-related activities

Key Responsibilities:

• Continuously monitor, gather, and analyse global pharmacovigilance regulatory intelligence from public and subscription‑based sources
• Perform initial assessments and coordinate reviews with relevant SMEs
• Collate impact assessments and communicate outcomes to stakeholders
• Facilitate impact analysis meetings and track implementation actions to completion
• Maintain regulatory intelligence trackers, action logs, and timelines
• Ensure timely submission of deliverables to the Global Regulatory Intelligence Organization (GRIO)
• Prepare metrics, dashboards, and presentations to visualize progress and challenges
• Support preparation of regulatory intelligence meeting materials and presentations
• Ensure documentation (e.g. audit trails, training records, presentations) is appropriately stored in Veeva and/or SharePoint
• Support vendor oversight activities and Maintain GPV vendor list
• Support updates to PSMF(s)
• Assist with management of shared GPV mailboxes

Position Requirements

• Bachelor’s degree in a life sciences discipline (minimum requirement)
• Good knowledge of global pharmaceutical / pharmacovigilance regulations (e.g. ICH, GVP)
• 1–2 years’ experience in pharmacovigilance, regulatory affairs, or quality assurance within the pharmaceutical or biotechnology industry
• Strong proficiency in Microsoft Office tools (Word, PowerPoint, Excel, SharePoint, Teams)
• Highly organised with the ability to manage multiple priorities and deadlines
• Excellent written, verbal, and interpersonal communication skills
• Strong attention to detail with solid analytical and problem‑solving skills
• Ability to work independently and adapt quickly in a fast‑paced environment

Kyowa Kirin International is an equal opportunities employer.

No agencies please.