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Job Details

Pharmacovigilance Manager

Company: Kyowa Kirin International plc
Location:
Reference: WSF5MA1
Closing Date: 16 Dec 17
Type: Full Time
Salary (£): Competitive
Benefits:

Job Summary:

We are recruiting for a Pharmacovigilance Manager to support preparation of submissions and launch activity, performing support activities for our current product range and new products as they are released.

Requirements:

With three product launches expected over the next three years, there has never been a more exciting time to join Kyowa Kirin.
We are recruiting for a Pharmacovigilance Manager to support preparation of submissions and launch activity, performing support activities for our current product range and new products as they are released.
Situated in the heart of the Scottish borders, you will join our Head office team in Galashiels, a short commute from Edinburgh.

Key Responsibilities:

  • Preparing aggregate reports, risk management plans, responses to requests for information from regulatory agencies and signal detection, evaluation and recommendation of appropriate actions.
  • Contributing to the preparation of regulatory submissions for new Marketing Authorisations
  • Working cross functionally with various departments including Regulatory Affairs, Clinical Development and Quality Assurance to develop and maintain core safety information and to represent the pharmacovigilance department within the projects team
  • Contributing to the preparation and implementation of required CAPA plans for drug safety activities while taking a leading role in inspections and audits
  • Participating in Global Safety Teams for global products marketed and / or developed in Japan, North American and / or the EAA.
  • Proactively review and update PV business procedures including SOP’s, guidelines and user manuals. Develop training courses for external/internal staff as requested.
  • Proactively identify efficiencies and improvements for Pharmacovigilance processes and make recommendations for change.
  • Any other drug safety related activity that may reasonably be required

About you:

You will be an experienced pharmacovigilance professional with the ability to analyse complex data and recognise potential obstacles while identifying resources required to see the task through to completion. You will have excellent communication skills with strong attention to detail and the ability to work effectively under pressure to meet department and regulatory deadlines.

To be successful in this role you will have:

  • Pharmacy, medical science degree or other healthcare qualification with significant direct involvement in drug safety/pharmacovigilance activities. A medical science background is preferable.
  • Expert knowledge and experience in pharmacovigilance medical writing, including for PBRERs/PSURs, Core Labelling (CCSI/CCDS) and Risk Management Plans.
  • In-depth knowledge of best drug safety/pharmacovigilance practices and drug safety regulations.
  • Technical knowledge of commercial drug safety databases (particularly with running and use of listings), MedDRA and WHO Drug coding.

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 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.

Apply for this job: Pharmacovigilance Manager

Contact Information:

Address:  Head Office
Galabank Business Park, Galashiels , Selkirkshire
TD1 1QH
Scotland
Tel:  +44 1896 664000
Website:  Visit Our Web Site

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