Pharmacovigilance Scientist

Recruiter
Kyowa Kirin International plc
Location
Edinburgh
Posted
17 Jan 2018
Closes
18 Feb 2018
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
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. We are currently recruiting for a Pharmacovigilance Scientist to support preparation of submissions and launch activity, performing support activities for our current product range and new products as they are released. This position will be based at our Global Head Office in Galashiels, less than an hour away from Edinburgh. Key Responsibilities: Provide scientific expertise during signal detection activities which drive benefit risk assessment reports, support of company core data sheets and other similar reports Provide scientific review and interpretation of safety data for preparation of aggregate reports such as Periodic Safety Update Reports (PSUR’s), Risk Management Plans (RMP’s) etc. Contribute to the preparation and review of pharmacovigilance documentation for internal and external use by providing scientific expertise to the preparation of responses to internal and external questions relating to the safe use of Kyowa Kirin products Scientifically review safety components of marketing authorisation applications (MAA, BLA and NDA) Stay up to date with regulatory guidance documents and pharmacovigilance processes. Review, update and implement business procedures and contribute to development training courses for external/internal staff. Support the quality of the work performed by the PV team ensuring that work is conducted to compliantly and to the highest quality standard. Be proactive in optimising processes based on departmental metrics. Work cross functionally within project teams to represent the pharmacovigilance department About you: You will be an experienced pharmacovigilance scientist with the ability to work effectively under pressure to meet department and regulatory deadlines. You will be extremely results driven with strong attention to detail and the ability to liaise effectively with other departments. To be successful in this role you will have: Pharmacy, Medical sciences degree or health professional qualification and broad experience working within a Pharmacovigilance Department Ability to produce high quality, accurate work to meet deadlines Well-developed scientific analytical skills with excellent communication skills and the ability to present findings and results effectively Working knowledge of regulatory requirements pertaining to pharmacovigilance in the pre and post approval environments Proactive approach with a drive to meet deadlines and see tasks to completion Experience in the use and management of Drug Safety Databases and MedDRA coding. Skilled in Microsoft Office applications Fluency in English Benefits: Competitive salary Pension scheme Private medical insurance Other voluntary benefits include: Childcare Vouchers, Bike to Work Location: You will be based at our Head Office in Galashiels, commutable from Edinburgh in less than an hour. Situated in the beautiful Scottish Borders, the local area provides affordable housing options with great infrastructure in terms of schooling, outdoor activities and transport. About us: 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.

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