At a Glance
- Tasks: Monitor and analyse global pharmacovigilance regulations while collaborating with experts.
- Company: Kyowa Kirin, a leading pharmaceutical company with a focus on innovation.
- Benefits: Competitive salary, flexible working options, and opportunities for professional growth.
- Other info: Fast-paced environment with excellent career development opportunities.
- Why this job: Join a dynamic team making a real impact in global health and safety.
- Qualifications: Bachelor's in life sciences and 1-2 years in pharmacovigilance or regulatory affairs.
The predicted salary is between 30000 - 40000 £ 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.
Specialist, GPV Performance Excellence - Monitoring Team (18-month FTC) in Marlow employer: Kyowa Kirin International plc.
Kyowa Kirin International plc is an exceptional employer, offering a dynamic work environment in the picturesque locations of Marlow, UK or Madrid, Spain. With a strong commitment to employee growth and development, the company fosters a collaborative culture where innovation thrives, and employees are encouraged to contribute to meaningful projects in pharmacovigilance. The benefits of working here include competitive remuneration, comprehensive training opportunities, and the chance to be part of a global team dedicated to improving patient safety.
Contact Details:
Kyowa Kirin International plc. Recruitment Team
StudySmarter Expert Advice🤫
We think this is how you could land Specialist, GPV Performance Excellence - Monitoring Team (18-month FTC) in Marlow
✨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 land you an interview.
✨Tip Number 2
Prepare for interviews by researching common questions related to pharmacovigilance and regulatory affairs. We recommend practising your answers with a friend or in front of a mirror to boost your confidence.
✨Tip Number 3
Showcase your skills! Create a portfolio or presentation that highlights your experience in monitoring and analysing regulatory intelligence. This can be a great conversation starter during interviews.
✨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 - Monitoring 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 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 a great 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 shows you’re keen on joining our team at StudySmarter!
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 that you really understand the field.
✨Showcase Your Organisational Skills
Since this role involves managing multiple priorities, be ready to share examples of how you've successfully juggled tasks in the past. Use specific instances where your organisational skills made a difference in your previous roles.
✨Prepare for Team Dynamics
You'll be working closely with subject matter experts and cross-functional teams. Think about how you can demonstrate your interpersonal skills and ability to collaborate effectively. Maybe have a story ready about a successful team project.
✨Visualise Your Impact
As part of the role, you'll need to prepare metrics and dashboards. Bring along any examples of presentations or reports you've created in the past. This will help you illustrate your analytical skills and attention to detail during the interview.
