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Job Details

Drug Safety Physician

Company: Kyowa Kirin International plc
Location: Galashiels, Edinburgh
Reference: 195747
Closing Date: 04 Nov 16
Type: Full Time
Salary (£): Competitive
Benefits: Pension, Private Medical Insurance, Income Protection, Life Assurance

Job Summary:

Ensure the safety of our products by providing medical analyses and input to meet international regulatory requirements and Company objectives


Drug Safety Physician

Location: Galashiels 

Kyowa Kirin International plc. (KKI) is entering an exciting pre-launch phase with an array of development and in-licensed global products which will join an expanding, successful product portfolio, focusing on cancer supportive care, oncology and bone therapeutic areas.

Our parent company Kyowa Hakko Kirin, based in Japan substantially reinvests into R&D to create products at both early and late stage development. With a focus on core business areas of oncology, nephrology, and immunology/allergy, together we leverage antibody-related leading-edge technologies, including our POTELLIGENT® Technology to discover and develop innovative new drugs aiming to become a global specialty pharmaceutical company which contributes to the health and well-being of people around the world. 

As a Drug Safety Physician with KKI, you will ensure the safety of our products by providing medical analyses and input to meet international regulatory requirements and Company objectives. You will support the VP Pharmacovigilance in increasing the department’s effectiveness and profile within Kyowa Kirin and the wider KHK Group and support the Qualified Person for Pharmacovigilance in Europe by contributing to the constant improvement of the Kyowa Kirin Pharmacovigilance System.

Key responsibilities will include ensuring high quality, accurate, timely medical contributions to the safety evaluation of Kyowa Kirin products by:

  • leading the therapeutic area team on the preparation of Benefit Risk Assessments,
  • the development of proactive risk management strategies for marketed and / or investigational compounds – working closely with Submission teams
  • leading signal detection activities including bringing medical expertise to drive Benefit Risk Assessment reports in addition to providing medical review and interpretation of safety data for preparation of aggregate reports such as Periodic Safety Update Reports (PSURs) and
  • ensuring that updated safety profiles of KKI products are provided to senior management

In addition, you will represent Pharmacovigilance at internal and external meetings where issues of drug safety are to be or may be discussed and maintain awareness of changes to regulatory guidance documents, requirements and state-or-the-art pharmacovigilance processes, making recommendations to ensure utmost effectiveness.  


Role Requirements:

  • Medically qualified physician with post-registration clinical experience and experience within pharmacovigilance or a related area of clinical development
  • Knowledge of regulatory requirements pertaining to pharmacovigilance in the pre and post approval environments is desirable
  • Excellent verbal and written English language, interpersonal, influencing and communication skills
  • Demonstrable managerial skills and leadership potential, with the ability to work in a matrix and across international cross-functional teams
  • Experience in the use and management of Drug Safety Databases and MedDRA coding and Microsoft Office applications

You will be rewarded with an excellent package, commensurate to the level of this role. This role is within the Pharmacovigilance department at KKI headquarters in Galashiels, Scotland.  Galashiels is within the beautiful Scottish Borders; Edinburgh being only a 50 minute commute away, providing you with the opportunity to truly appreciate the great outdoors and city living. This role will also offer you the opportunity of global travel.

Apply for this job: Drug Safety Physician

Contact Information:

Address:  Head Office
Galabank Business Park, Galashiels , Selkirkshire
Tel:  +44 1896 664000
Website:  Visit Our Web Site

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