At a Glance
- Tasks: Support pharmacovigilance quality management and ensure compliance in a dynamic team.
- Company: Join Kyowa Kirin, a leader in life sciences with a collaborative culture.
- Benefits: Gain valuable experience in a high-performing environment with career advancement opportunities.
- Other info: Flexible, proactive mindset needed; excellent communication and organisational skills are a must.
- Why this job: Make a real impact in patient safety and quality assurance within the pharma industry.
- Qualifications: Bachelor’s in life sciences and experience in pharmacovigilance or quality assurance required.
The predicted salary is between 40000 - 50000 £ per year.
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, prioritise 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 in Marlow employer: Kyowa Kirin
Kyowa Kirin is an exceptional employer that fosters a collaborative and high-performing work culture, particularly in the vibrant setting of Marlow, UK. Employees benefit from continuous professional development opportunities, a commitment to diversity and inclusion, and the chance to contribute meaningfully to the advancement of pharmacovigilance practices. With a focus on quality and compliance, this role offers a unique opportunity to grow within a supportive team dedicated to excellence in healthcare.
StudySmarter Expert Advice🤫
We think this is how you could land Specialist, GPV Performance Excellence in Marlow
✨Tip Number 1
Network like a pro! Reach out to people in the pharmacovigilance and quality assurance fields. Use LinkedIn or industry events to connect with professionals who can give you insights or even refer you to opportunities.
✨Tip Number 2
Prepare for interviews by researching Kyowa Kirin and their GPV Performance Excellence team. Understand their values and recent projects, so you can show how your skills align with their goals during the chat.
✨Tip Number 3
Practice common interview questions related to pharmacovigilance and quality management. We recommend doing mock interviews with friends or mentors to boost your confidence and refine your answers.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, it shows you’re genuinely interested in joining our team at Kyowa Kirin.
We think you need these skills to ace Specialist, GPV Performance Excellence in Marlow
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Specialist, GPV Performance Excellence role. Highlight your experience in pharmacovigilance or quality assurance, and don’t forget to mention any relevant skills like your understanding of GVP and ICH guidelines.
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you’re passionate about this role and how your background makes you a perfect fit for our Global Pharmacovigilance team. Keep it concise but impactful!
Showcase Your Skills:We want to see your strong Microsoft Office skills in action! If you’ve got experience with tools like Word, Excel, and SharePoint, make sure to highlight that in your application. It’s all about showing us you can hit the ground running.
Apply Through Our Website:Don’t forget to apply through our website! It’s the best way to ensure your application gets to us directly. Plus, it shows you’re keen on joining our team at Kyowa Kirin. We can’t wait to hear from you!
How to prepare for a job interview at Kyowa Kirin
✨Know Your Stuff
Make sure you brush up on your pharmacovigilance and quality assurance knowledge. Familiarise yourself with GVP and ICH guidelines, as well as the specific responsibilities of the role. This will not only help you answer questions confidently but also show that you're genuinely interested in the position.
✨Showcase Your Experience
Prepare to discuss your previous experience in managing deviations, CAPAs, and compliance metrics. Use specific examples from your past roles to illustrate how you've contributed to audit readiness or improved processes. This will demonstrate your practical knowledge and problem-solving abilities.
✨Be Organised
Since the role involves a lot of document management and coordination, it’s crucial to show your organisational skills. Bring a notebook or digital device to jot down important points during the interview, and be ready to discuss how you prioritise tasks and manage multiple responsibilities effectively.
✨Ask Smart Questions
Prepare thoughtful questions about the team dynamics, ongoing projects, or the company’s approach to continuous improvement in pharmacovigilance. This shows that you’re not just interested in the job, but also in how you can contribute to the team and grow within the company.
