At a Glance
- Tasks: Support pharmacovigilance quality management and ensure compliance in a dynamic team.
- Company: Kyowa Kirin International, a caring and innovative pharmaceutical company.
- Benefits: Inclusive culture, career advancement, and the chance to make a real difference.
- Other info: Opportunity for growth in a collaborative environment.
- Why this job: Join a high-performing team and contribute to life-changing solutions.
- Qualifications: Bachelor’s in life sciences and experience in pharmacovigilance or quality assurance.
The predicted salary is between 40000 - 50000 € per year.
Overview
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.
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
Qualifications
- 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.
Specialist, GPV Performance Excellence - Optimization Team (18-month FTC) employer: Kyowa Kirin International
At Kyowa Kirin International, we are dedicated to pushing the boundaries of medicine while fostering a culture of teamwork, innovation, and integrity. Located in Marlow, UK, we offer a collaborative environment where employees can thrive and grow, supported by our commitment to continuous improvement and patient care. With opportunities for professional development and a focus on making a meaningful impact, KKI is an exceptional employer for those looking to advance their careers in the pharmaceutical industry.
StudySmarter Expert Advice🤫
We think this is how you could land Specialist, GPV Performance Excellence - Optimization Team (18-month FTC)
✨Tip Number 1
Network like a pro! Reach out to people in the industry, especially those at Kyowa Kirin. A friendly chat can open doors and give you insights that a job description just can't.
✨Tip Number 2
Prepare for interviews by practising common questions related to pharmacovigilance and quality assurance. We recommend using the STAR method to structure your answers – it helps you showcase your experience effectively!
✨Tip Number 3
Show off your skills! Bring examples of your work or projects that highlight your experience in managing deviations and CAPAs. This will demonstrate your hands-on knowledge and commitment to excellence.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive about their job search.
We think you need these skills to ace Specialist, GPV Performance Excellence - Optimization Team (18-month FTC)
Some tips for your application 🫡
Tailor Your CV:Make sure your CV reflects the skills and experiences that align with the Specialist, GPV Performance Excellence role. Highlight your background in pharmacovigilance or quality assurance, and don’t forget to mention any relevant projects or achievements!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you’re passionate about making a difference in the pharmaceutical industry and how your values align with Kyowa Kirin’s commitment to care and innovation.
Showcase Your Skills:When filling out your application, be sure to emphasise your strong Microsoft Office skills and your understanding of GVP and ICH guidelines. We want to see how you can contribute to our high-performing environment!
Apply Through Our Website:We encourage you to apply directly through our website for the best chance of success. It’s the easiest way for us to receive your application and get to know you better!
How to prepare for a job interview at Kyowa Kirin International
✨Know Your Stuff
Make sure you brush up on your pharmacovigilance and quality assurance knowledge. Understand the GVP and ICH guidelines inside out, as these will likely come up in conversation. Being able to discuss specific examples from your experience will show that you're not just familiar with the concepts but can apply them effectively.
✨Showcase Your Team Spirit
Kyowa Kirin values teamwork, so be ready to share examples of how you've collaborated with others in previous roles. Think about times when you contributed to a team project or helped resolve conflicts. This will demonstrate that you align with their culture and can thrive in a collaborative environment.
✨Be Organised and Detail-Oriented
Given the role's focus on compliance metrics and document management, highlight your organisational skills. Bring examples of how you've maintained records or managed projects with high attention to detail. This will reassure them that you can handle the responsibilities of the position effectively.
✨Ask Insightful Questions
Prepare some thoughtful questions about the role and the company culture. Inquire about their approach to continuous improvement in pharmacovigilance or how they support employee development. This shows your genuine interest in the position and helps you assess if it's the right fit for you.
