At a Glance
- Tasks: Monitor and analyse global pharmacovigilance regulations to ensure compliance and support impactful decision-making.
- Company: Kyowa Kirin International, a caring and innovative pharmaceutical company.
- Benefits: Competitive salary, inclusive culture, and opportunities for professional growth.
- Other info: Dynamic role with a focus on teamwork and integrity in a fast-paced environment.
- Why this job: Join a team that makes a real difference in people's lives through innovative healthcare solutions.
- Qualifications: Bachelor's in life sciences and 1-2 years in pharmacovigilance or regulatory affairs.
The predicted salary is between 30000 - 40000 £ 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 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.
Key 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
Position Requirements
- 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
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 supportive work environment that prioritises employee growth and development, ensuring that our team members can thrive both personally and professionally. With a commitment to making a meaningful impact on patients' lives, we provide unique opportunities for collaboration and engagement in the pharmaceutical industry, making KKI an exceptional place to build your career.
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 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 knowing your stuff! Research Kyowa Kirin's values and recent projects. Show them you’re not just another candidate; you’re genuinely interested in making a difference.
✨Tip Number 3
Practice makes perfect! Do mock interviews with friends or use online resources. The more comfortable you are talking about your experience and skills, the better you'll shine during the real deal.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen. Plus, it shows you’re serious about joining the team at Kyowa Kirin.
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 can contribute to our mission!
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 background aligns with our values at Kyowa Kirin. Remember, we love innovation and teamwork, so let that come through in your writing.
Showcase Your Skills:Don’t forget to mention your proficiency in Microsoft Office tools and any experience with regulatory intelligence activities. We’re looking for someone who can hit the ground running, so make sure we know what you bring to the table!
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 serious about joining our team!
How to prepare for a job interview at Kyowa Kirin International
✨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 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. Highlight how you kept everything on track, especially in fast-paced environments.
✨Communicate Clearly
Practice articulating your thoughts clearly and concisely. Whether it's discussing your experience or answering questions, strong communication skills are key. Consider doing mock interviews with a friend to refine your delivery.
✨Prepare for Teamwork Questions
Given the emphasis on teamwork at Kyowa Kirin, think of specific instances where you collaborated effectively with others. Be ready to discuss how you contributed to team success and how you handle conflicts or differing opinions.
