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- Tasks: Lead global safety teams to ensure patient safety and regulatory compliance for innovative products.
- Company: Kyowa Kirin International, a caring and inclusive pharmaceutical company.
- Benefits: Competitive salary, inclusive culture, and opportunities for professional growth.
- Why this job: Make a real difference in patients' lives while pushing the boundaries of medicine.
- Qualifications: Medically qualified physician with pharmacovigilance experience and strong communication skills.
- Other info: Work in a dynamic, international environment with excellent career advancement opportunities.
The predicted salary is between 72000 - 108000 £ per year.
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 are 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: We are looking for a Physician to contribute to the understanding and monitoring of the safety profile of the Kyowa Kirin products by:
- Leading Global Safety Team(s) to develop safety strategies for ensuring patient safety and regulatory compliance for assigned products in development and/or marketing.
- Providing medical analyses and input to meet international regulatory requirements and Company objectives.
- Supporting the VP Pharmacovigilance in increasing the department's effectiveness and profile within Kyowa Kirin and the wider KHK Group.
- Supporting the Qualified Person for Pharmacovigilance in Europe by contributing to the constant improvement of the Kyowa Kirin Pharmacovigilance System.
This position could be based in any of our UK or European based offices (France, Germany, Netherlands, Spain, Italy).
Key Responsibilities:
- Ensure high quality, accurate, timely medical contributions to the safety evaluation of Kyowa Kirin products by leading Global Safety Team(s).
- Determine the safety strategy for the preparation of regulatory submissions for new Marketing Authorisation Approvals in any region/country.
- Lead the preparation of Benefit Risk Assessments for Kyowa Kirin products.
- Develop appropriate risk management strategies for marketed and/or investigational compounds.
- Lead signal detection activities using data from all sources.
- Provide medical review and interpretation of safety data for preparation of aggregate reports.
- Contribute to the preparation and review of pharmacovigilance documentation.
- Ensure that updated safety profiles of Kyowa Kirin products are provided to senior management as required.
- Represent Pharmacovigilance at internal and external meetings.
- Maintain awareness of changes to regulatory guidance documents and make recommendations.
- Work cross-functionally within project teams to meet Company objectives.
Qualifications:
- Medically qualified physician with post-registration clinical experience and strong experience within pharmacovigilance or related area of clinical development.
- Knowledge of regulatory requirements pertaining to pharmacovigilance in the pre and post approval environments is preferred.
- Fluent in English.
- Excellent verbal, written, interpersonal, influencing and communication skills.
- Ability to produce high quality, accurate work to meet deadlines.
- Demonstrable managerial skills and leadership potential.
- Ability to work in a matrix, remote organization and international cross-functional teams.
- Experience in the use and management of Drug Safety Databases and MedDRA coding.
- Skilled in Microsoft Office applications (Word, PowerPoint and Excel).
Kyowa Kirin International is an equal opportunities employer. No agencies please.
Director, Pharmacovigilance employer: Kyowa Kirin International
Contact Detail:
Kyowa Kirin International Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Director, Pharmacovigilance
✨Tip Number 1
Network like a pro! Reach out to people in the industry, attend events, and connect on LinkedIn. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by researching the company and its culture. Understand their values, like teamwork and innovation, so you can show how you fit right in. Tailor your answers to reflect what they care about!
✨Tip Number 3
Practice makes perfect! Do mock interviews with friends or use online resources to get comfortable with common questions. The more you practice, the more confident you'll feel when it’s time to shine.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen. Plus, we love seeing candidates who are proactive and engaged with our mission to make people smile.
We think you need these skills to ace Director, Pharmacovigilance
Some tips for your application 🫡
Show Your Passion: When writing your application, let your enthusiasm for pharmacovigilance shine through! We want to see how your passion aligns with our mission to make people smile and ensure patient safety.
Tailor Your CV: Make sure to customise your CV to highlight relevant experience in pharmacovigilance and clinical development. We love seeing how your background fits with our values of teamwork and innovation!
Be Clear and Concise: Keep your written application clear and to the point. We appreciate well-structured documents that convey your qualifications without unnecessary fluff. Remember, quality over quantity!
Apply Through Our Website: Don’t forget to submit your application through our website! It’s the best way for us to receive your details and ensures you’re considered for this exciting opportunity at Kyowa Kirin.
How to prepare for a job interview at Kyowa Kirin International
✨Know Your Stuff
Make sure you brush up on pharmacovigilance regulations and the specific safety strategies relevant to Kyowa Kirin's products. Familiarise yourself with their recent developments and how they align with patient safety and regulatory compliance.
✨Showcase Your Leadership Skills
As a Director, you'll need to lead Global Safety Teams. Prepare examples of your past leadership experiences, especially in cross-functional teams. Highlight how you've successfully driven projects and influenced outcomes in a matrix organisation.
✨Communicate Clearly
Excellent communication is key in this role. Practice articulating complex medical concepts in simple terms. Be ready to discuss how you would present safety data and risk management strategies to both technical and non-technical stakeholders.
✨Align with Company Values
Kyowa Kirin values teamwork, commitment, innovation, and integrity. Think about how your personal values align with these and prepare to share specific examples that demonstrate your commitment to these principles in your work.
