At a Glance
- Tasks: Support PV procedures and manage training for personnel in a dynamic pharmaceutical environment.
- Company: Kyowa Kirin International, a caring and innovative pharmaceutical company.
- Benefits: Inclusive culture, career growth opportunities, and a commitment to making a difference.
- Other info: Collaborative team environment with a focus on innovation and integrity.
- Why this job: Join us to make a real impact on patient care and drive life-changing solutions.
- Qualifications: Attention to detail, experience in pharma, and strong communication skills are essential.
The predicted salary is between 50000 - 65000 £ per year.
Location: Marlow, UK
Company: Kyowa Kirin International plc
WE PUSH THE BOUNDARIES OF MEDICINE. LEAPING FORWARD TO MAKE PEOPLE SMILE.
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. They help us to push boundaries to deliver extraordinary impact and make KKI a brilliant place to work.
Job Purpose
This role supports with PV procedures and change controls management and monitoring. This role may coordinate all PV and certain PV vendor personnel training relevant to their roles and ensure that all Kyowa Kirin employees receive periodic PV training to enable the timely identification and reporting of adverse events.
Key Responsibilities
- Coordinates PV procedures management through their lifecycle, including periodic review management, coordination of editing and review workflows in electronic document management system.
- Supports with periodic document management committee meetings preparation and conduct.
- Supports GPV stakeholders in change controls management.
- Performs PV procedures and change controls status monitoring and prepares periodic metrics.
- Maintains GPV training curricula across all PV job roles and coordinates the training of all PV and PV-relevant procedures for GPV personnel and certain PV vendor personnel.
- Supports with maintenance of GPV training curricula and learner profiles up to date.
- Monitors training compliance and prepares periodic training compliance metrics.
- Coordinates GPV personnel and vendor access to electronic quality document system.
- Supports with identification of opportunities for future performance optimisation and subsequent implementation of agreed initiatives, as applicable.
Position Requirements
- High attention to detail and focus on quality.
- Previous experience working with multiple stakeholders within a complex matrix organisation.
- Previous experience in pharmaceutical, GCP and/or GVP related environment preferred.
- Previous experience in supporting projects preferred.
- Previous experience in managing reports and data preferred.
- Highly skilled in use of Microsoft Office applications and databases or electronic data management systems.
- Good communication and presentation skills.
- Proven skills in being accountable, impactful, and willingness to confront problems.
Kyowa Kirin International is an equal opportunities employer.
Senior Specialist, GPV Performance Excellence in Marlow employer: Kyowa Kirin
At Kyowa Kirin International, we pride ourselves on being an inclusive and innovative pharmaceutical company that prioritises the well-being of our employees and the communities we serve. Located in Marlow, UK, we offer a collaborative work culture rooted in our core values of Teamwork, Commitment to Life, Innovation, and Integrity, providing ample opportunities for professional growth and development. Join us to be part of a team that not only pushes the boundaries of medicine but also fosters a supportive environment where your contributions truly make a difference.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Specialist, GPV Performance Excellence in Marlow
✨Tip Number 1
Network like a pro! Reach out to current or former employees at Kyowa Kirin through LinkedIn. A friendly chat can give you insider info about the company culture and maybe even a referral!
✨Tip Number 2
Prepare for the interview by researching common questions for roles in GPV and performance excellence. We recommend practising your answers with a friend to boost your confidence and ensure you hit all the key points.
✨Tip Number 3
Showcase your skills! During the interview, be ready to discuss specific examples of how you've managed projects or improved processes in previous roles. This will demonstrate your ability to deliver impact at KKI.
✨Tip Number 4
Don’t forget to follow up after your interview! A quick thank-you email reiterating your enthusiasm for the role can leave a lasting impression and keep you top of mind for the hiring team.
We think you need these skills to ace Senior Specialist, GPV Performance Excellence in Marlow
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Senior Specialist role. Highlight your experience in PV procedures and change controls, and don’t forget to showcase your attention to detail and quality focus. We want to see how you can push boundaries in this field!
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. Share specific examples of how you've worked with stakeholders in complex environments, as this aligns with our values at Kyowa Kirin.
Showcase Your Skills:Don’t hold back on showcasing your skills in Microsoft Office and electronic data management systems. We love candidates who are tech-savvy and can manage reports and data effectively. Make sure to mention any relevant projects you’ve supported 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 get to know you better. Plus, it shows you’re keen on joining our team at Kyowa Kirin!
How to prepare for a job interview at Kyowa Kirin
✨Know Your Stuff
Make sure you’re well-versed in the specifics of pharmacovigilance (PV) and change control management. Brush up on relevant regulations and best practices, as well as Kyowa Kirin's values and mission. This will show that you’re not just interested in the role but also genuinely care about their purpose.
✨Showcase Your Experience
Prepare to discuss your previous experiences in managing reports, data, and working with multiple stakeholders. Use specific examples that highlight your attention to detail and ability to navigate complex environments. This will demonstrate your capability to thrive in a matrix organisation like Kyowa Kirin.
✨Be Ready for Scenario Questions
Expect questions that assess how you would handle real-life situations related to PV procedures and training compliance. Think through potential challenges you might face in the role and how you would address them. This shows your problem-solving skills and readiness to take bold actions.
✨Communicate Clearly
Practice your communication and presentation skills before the interview. You’ll need to convey complex information clearly and effectively, so consider doing mock interviews with friends or colleagues. This will help you feel more confident and articulate during the actual interview.