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
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’s 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)
Responsibilities- Ensure high quality, accurate, timely medical contributions to the safety evaluation of Kyowa Kirin products by leading Global Safety Team(s) to:
- Ensure the safe development of new products and timely and effective contributions of safety to Development teams including the identification and implementation of safety strategies to deliver Company objectives for products in both development and the market.
- Determine the safety strategy for the preparation of regulatory submissions for new Marketing Authorisation Approvals in any region /country and ensure the delivery of high quality safety documentation for those submissions.
- Lead the preparation of Benefit Risk Assessments for Kyowa Kirin products and provide appropriate support for implementation of the associated conclusions.
- Develop appropriate risk management strategies for marketed and / or investigational compounds ensuring that these are contained and implemented in appropriate way including Risk Management Plans. Ensure success of such activities by close liaison with Submission teams.
- Lead signal detection activities using data from all sources and bring medical expertise to drive Benefit Risk assessment reports, provide safety input for the Company Core Data Sheets and other similar reports and actions.
- Provide medical review and interpretation of safety data for preparation of aggregate reports and ensure consistent messaging across all such reports and documents issued for both development and postmarketing purposes.
- Contribute to the preparation and review of pharmacovigilance documentation for internal and external use by providing medical expertise to the preparation of responses to internal and external questions relating to the safe use of Kyowa Kirin products, safety issue work up etc.
- Ensure that updated safety profiles of Kyowa Kirin products are provided to senior management as required.
- Represent Pharmacovigilance at internal and external meetings where issues of drug safety are to be, or may be, discussed.
- Maintain awareness of changes to regulatory guidance documents, requirements and state-or-the-art pharmacovigilance processes and make recommendations leading to the improvement of the effectiveness and profile of the department.
- To work cross functionally within project teams to meet Company objectives and to represent the Department of Pharmacovigilance in a team oriented manner and delivering quality and timely input to meet the needs of the project team
Position Requirements
- MANDATORY: Medically qualified physician with post-registration clinical experience and a strong experience within pharmacovigilance or related area of clinical development; specialist training or clinical exposure in immunology and/or haemato‑oncology strongly preferred
- 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 with emphasis on building consensus
- Ability to produce high quality, accurate work (oral written and presentation) to meet deadlines.
- Demonstrable managerial skills and leadership potential
- Ability to work in a matrix, remote organization and international cross-functional teams
- Strong focus on producing key deliverables (quality/time/costs)
- Experience in the use and management of Drug Safety Databases and MedDRA coding. Skilled in Microsoft Office applications (Word, PowerPoint and Excel).