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- Tasks: Monitor and analyse global pharmacovigilance regulations while collaborating with experts.
- Company: Kyowa Kirin, a leading pharmaceutical company with a commitment to excellence.
- Benefits: Competitive salary, professional development, and a dynamic work environment.
- Other info: Fast-paced role with opportunities for growth and learning.
- Why this job: Join a vital team ensuring safety in pharmaceuticals and make a real difference.
- Qualifications: Bachelor's in life sciences and 1-2 years in pharmacovigilance or regulatory affairs.
The predicted salary is between 30000 - 40000 ÂŁ per year.
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.
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
Qualifications
- 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.
Specialist, GPV Performance Excellence - Monitoring Team (18-month FTC) employer: Kyowa Kirin International plc.
Contact Detail:
Kyowa Kirin International plc. Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Specialist, GPV Performance Excellence - Monitoring Team (18-month FTC)
✨Tip Number 1
Network like a pro! Reach out to people in the industry, especially those who work at Kyowa Kirin or similar companies. A friendly chat can open doors and give you insights that might just help you stand out.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of pharmacovigilance regulations. Be ready to discuss how your experience aligns with the role. We want to see your passion and expertise shine through!
✨Tip Number 3
Showcase your organisational skills! During interviews, share examples of how you've managed multiple priorities or deadlines. This will demonstrate that you're the perfect fit for a fast-paced environment like Kyowa Kirin.
✨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 take the initiative to connect directly with us.
We think you need these skills to ace Specialist, GPV Performance Excellence - Monitoring Team (18-month FTC)
Some tips for your application 🫡
Tailor Your CV: Make sure your CV reflects the skills and experiences that match the job description. Highlight your knowledge of pharmacovigilance regulations and any relevant experience in the pharmaceutical industry. We want to see how you fit into our team!
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 the perfect fit. Don’t forget to mention your organisational skills and attention to detail, as these are key for us.
Showcase Your Communication Skills: Since this role involves working with various stakeholders, it's important to demonstrate your excellent written and verbal communication skills. Use clear and concise language in your application to show us you can communicate effectively.
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it’s super easy to do!
How to prepare for a job interview at Kyowa Kirin International plc.
✨Know Your Stuff
Make sure you brush up on global pharmacovigilance regulations like ICH and GVP. Being able to discuss these confidently will show that you’re not just familiar with the basics but also understand the nuances of the role.
✨Showcase Your Organisational Skills
Since this role requires managing multiple priorities, prepare examples from your past experiences where you successfully juggled tasks. Use the STAR method (Situation, Task, Action, Result) to structure your responses.
✨Be Ready to Collaborate
This position involves working closely with subject matter experts and stakeholders. Think of times when you’ve worked in a team or facilitated meetings, and be ready to share how you contributed to successful outcomes.
✨Prepare Visuals
Since you'll need to prepare metrics and presentations, consider bringing a sample dashboard or visual representation of data you've worked with before. This can help demonstrate your proficiency in Microsoft Office tools and your ability to communicate complex information clearly.