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.
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.
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.
Specialist, GPV Performance Excellence - Optimization Team (18-month FTC) in Marlow 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) in Marlow
✨Tip Number 1
Network like a pro! Reach out to current or former employees at Kyowa Kirin on LinkedIn. A friendly chat can give you insider info and maybe even a referral, which can really boost your chances.
✨Tip Number 2
Prepare for the interview by researching the company culture and values. Kyowa Kirin values teamwork and innovation, so think of examples from your past that showcase these traits. We want to see how you fit into their mission!
✨Tip Number 3
Practice common interview questions, but also be ready for situational ones. Think about how you would handle specific challenges in pharmacovigilance or quality assurance. Show us your problem-solving skills!
✨Tip Number 4
Don’t forget to follow up after your interview! A quick thank-you email can leave a lasting impression. It shows your enthusiasm for the role and keeps you fresh in their minds. And remember, apply through our website for the best chance!
We think you need these skills to ace Specialist, GPV Performance Excellence - Optimization Team (18-month FTC) in Marlow
Some tips for your application 🫡
Tailor Your CV:Make sure your CV reflects the skills and experiences that match the job description. 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 the role and how your values align with Kyowa Kirin’s mission. Keep it concise but impactful!
Showcase Your Skills:Don’t just list your skills; demonstrate them! Use specific examples from your past experiences to show how you’ve successfully managed deviations, CAPAs, or contributed to compliance metrics.
Apply Through Our Website:We encourage you to apply directly through our website for the best chance of being noticed. It’s quick and easy, and we can’t wait to see your application come through!
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 Skills
Highlight your strong Microsoft Office skills during the interview. Be ready to discuss how you've used tools like Excel for compliance metrics or Word for document management. This will demonstrate your technical proficiency and how it aligns with the role's requirements.
✨Emphasise Teamwork
Kyowa Kirin values teamwork, so be prepared to share examples of how you've collaborated with others in previous roles. Discuss any cross-functional projects you've been involved in and how you contributed to achieving common goals. This will show that you fit well within their culture.
✨Ask Insightful Questions
Prepare some thoughtful questions about the company's approach to continuous improvement in pharmacovigilance. This shows your genuine interest in the role and helps you understand how you can contribute to their mission of making people smile. It’s a great way to engage with the interviewers and leave a lasting impression.
