At a Glance
- Tasks: Monitor and analyse global pharmacovigilance regulatory intelligence to ensure compliance.
- Company: Kyowa Kirin International, a caring and innovative pharmaceutical company.
- Benefits: Inclusive culture, career development, and the chance to make a real difference.
- Other info: Dynamic role with opportunities for growth in a fast-paced environment.
- Why this job: Join a team that pushes boundaries in medicine and impacts lives positively.
- 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.
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) 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 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 those looking to contribute to life-changing solutions in the pharmaceutical industry.
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 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 practising common questions related to pharmacovigilance and regulatory affairs. We recommend using the STAR method to structure your answers – it helps you showcase your experience effectively!
✨Tip Number 3
Showcase your skills with a portfolio! If you've worked on relevant projects or have presentations, gather them together. This gives you a chance to demonstrate your expertise beyond just words.
✨Tip Number 4
Don't forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. 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 - Monitoring Team (18-month FTC) in Marlow
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the role of Specialist, GPV Performance Excellence. Highlight your experience in pharmacovigilance and any relevant skills that match the job description. 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 making a difference in the pharmaceutical industry and how your values align with ours at Kyowa Kirin. Let us know what makes you tick!
Showcase Your Skills:Don’t forget to highlight your proficiency in Microsoft Office tools and your organisational skills. We love candidates who can juggle multiple priorities, so give us examples of how you've done this in the past!
Apply Through Our Website:We encourage you to apply through our website for a smoother application process. It’s the best way for us to receive your application and keep track of it. Plus, it shows you’re keen on 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 also understand how they apply to the role.
✨Showcase Your Organisational Skills
Since this role requires managing multiple priorities, prepare examples of how you've successfully juggled tasks in the past. Use the STAR method (Situation, Task, Action, Result) to structure your responses.
✨Communicate Clearly
Practice articulating your thoughts clearly and concisely. This is crucial for the role, especially when discussing impact assessments or presenting metrics. Consider doing mock interviews with a friend to refine your communication style.
✨Be Ready to Adapt
The job mentions a fast-paced environment, so be prepared to discuss times when you had to adapt quickly to changes. Highlight your problem-solving skills and how you can maintain quality under pressure.
