Drug Safety Physician
With three product launches expected over the next three years, there has never been a more exciting time to join Kyowa Kirin. We are currently recruiting for a Drug Safety Physician to support the transitioning of products from development to marketing, post marketing activity, providing medical analyses and supporting the VP Pharmacovigilance in increasing the department’s effectiveness and profile within Kyowa Kirin and the wider KHK Group. Key Responsibilities: Contribute to the preparation of regulatory submissions for new Marketing Authorisation Approvals in EAA and USA Lead the preparation of Benefit Risk Assessments for Kyowa Kirin products and develop proactive risk management strategies for marketed and/or investigational compounds Lead signal detection activities using data from all sources and bring medical expertise to drive Benefit Risk assessment reports, support of Company Core Data Sheets and other similar reports and actions Provide medical review and interpretation of safety data for preparation of aggregate reports such as Periodic Safety Update Reports (PSURs) 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 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 Ensure that Ethics and Medical Compliance is applied within all pharmacovigilance activities About you: You will be an experienced drug safety professional with excellent communication skills and the ability to proactively prioritise and manage multiple projects. With a strong focus on key deliverables, you will use your analytical skills to present complex data in an accurate and understandable manner. Candidate Profile: Medically qualified physician with post-registration clinical experience and significant experience within pharmacovigilance or related area of clinical development Knowledge of regulatory requirements pertaining to pharmacovigilance in the pre and post approval environments is desirable 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 Experience in the use and management of Drug Safety Databases and MedDRA coding. Skilled in Microsoft Office applications (Word, PowerPoint and Excel). Fluent in English Benefits: Competitive salary Pension scheme Private medical insurance Other voluntary benefits include: Childcare Vouchers, Bike to Work Location: This role will be located within the KKI headquarters of Galashiels, Scotland, or possibly from a London based office. About us: Kyowa Kirin International is going through an exceptional time. With three product launches expected over the next three years and further new product development, combined with excellent international growth rates; we are providing a great platform for today and our future. Kyowa Kirin International plc is owned by Kyowa Hakko Kirin Co., Ltd (KHK) of Japan. Founded in 1949, KHK has a successful track record in Japan and is now expanding globally. Our highly successful product portfolio, enviable pipeline and active Business Development group provides a wealth of products in the therapeutic areas of Oncology, CNS and Nephrology. With three key anti-body therapies in late stage development Kyowa Kirin is setting the scene for transformative growth. Kyowa Kirin International is an equal opportunities employer.