At a Glance
- 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 Β£ 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. 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.
Position Requirements:
- 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.
- 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 in Marlow employer: Kyowa Kirin International
Contact Detail:
Kyowa Kirin International Recruiting Team
StudySmarter Expert Advice π€«
We think this is how you could land Director, Pharmacovigilance in Marlow
β¨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.
β¨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 their mission of making people smile!
β¨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 itβs time to shine.
β¨Tip Number 4
Donβt forget to apply through our website! Itβs 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 Director, Pharmacovigilance in Marlow
Some tips for your application π«‘
Tailor Your Application: Make sure to customise your CV and cover letter for the Director, Pharmacovigilance role. Highlight your relevant experience in pharmacovigilance and any specific skills that align with the job description. We want to see how you can contribute to our mission!
Showcase Your Medical Expertise: As a medically qualified physician, it's crucial to emphasise your clinical experience and knowledge of regulatory requirements. Share examples of how you've successfully navigated safety evaluations or contributed to risk management strategies in your previous roles.
Communicate Clearly: Your written communication skills are key! Ensure your application is clear, concise, and free of jargon. We appreciate straightforward language that gets to the point while still showcasing your personality and passion for the role.
Apply Through Our Website: We encourage you to submit your application directly through our website. This way, we can ensure your application is reviewed promptly and youβre considered for this exciting opportunity to make a difference at Kyowa Kirin!
How to prepare for a job interview at Kyowa Kirin International
β¨Know Your Stuff
Make sure you brush up on pharmacovigilance principles and regulatory requirements. Familiarise yourself with Kyowa Kirin's products and their safety profiles. This will not only show your expertise but also demonstrate your genuine interest in the role.
β¨Showcase Your Leadership Skills
As a Director, you'll be leading Global Safety Teams. Prepare examples of how you've successfully led teams in the past, particularly in high-pressure situations. Highlight your ability to drive consensus and influence others, as this is crucial for the role.
β¨Communicate Clearly
Excellent communication skills are key for this position. Practice articulating complex medical information in a clear and concise manner. You might even want to prepare a mock presentation on a relevant topic to showcase your ability to convey important safety data effectively.
β¨Emphasise Teamwork and Innovation
Kyowa Kirin values teamwork and innovation. Be ready to discuss how you've collaborated with cross-functional teams and contributed to innovative solutions in your previous roles. Share specific examples that align with their company culture and values.