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Job Details

International PV Audit and Compliance Manager

Company: Kyowa Kirin International plc
Location: Galashiels, Edinburgh
Reference: 249454
Closing Date: 23 Jan 17
Type: Full Time
Salary (£): Competitive
Benefits: Pension, Private Medical Insurance, Income Protection, Life Assurance

Job Summary:

Carry out Good Pharmacovigilance Practice (GVP) audits of our Global PV systems, affiliates, and additional audits as required and collaborate closely with our dedicated Pharmacovigilance team


International Pharmacovigilance Audit and Compliance Manager

Location: Galashiels, Edinburgh 

Kyowa Kirin International plc. Is a leading biopharmaceutical company with headquarters in Japan whose substantial reinvestment into R&D is creating products at both early and late stage development. With a focus on core business areas of oncology, nephrology, and immunology/allergy, Kyowa Kirin leverages antibody-related leading-edge technologies, including its 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. 

We are 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.

As a key member of Kyowa Kirin’s Quality Assurance department, you will carry out Good Pharmacovigilance Practice (GVP) audits of our Global PV systems, affiliates, and additional audits as required and collaborate closely with our dedicated Pharmacovigilance team.

Key Responsibilities will include:

  • Prepare a risk based, tactical level (annual) PV audit plan for Kyowa Kirin International.
  • Follow up post audit CAPA’s and actions.
  • Collaborate with EEA QPPV and Head of Global Drug Safety to develop audit strategy.
  • To compile and maintain a strategic, risk based, long term, rolling plan of scheduled and completed audits.
  • Contribute to the compilation of the relevant quality system sections of the PSMF and annexes.
  • Support other GxP audits (depending on experience).
  • Host/ support GVP audits.

Position Requirements:

  • A Life Science Degree or equivalent
  • Experience of working in the Pharmaceutical Industry, with significant experience working within a Pharmacovigilance audit capacity
  • Excellent working knowledge of international GVP’s especially in the interpretation of MHRA, EMA and FDA requirements for commercial products and clinical trial materials
  • Excellent working knowledge of global PV regulations, including EMA, FDA regulations and ICH
  • Experience of Japanese PV regulations would be highly desirable
  • Experience in compliance and quality system management including development of SOP’s, CAPA management and training in PV organisations
  • Familiar with Quality Management Systems e.g. quality risk management.
  • Regular Worldwide Travel (50-70%)

You will be rewarded with an excellent package, commensurate to the level of this role, and will be based in Galashiels 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.

Apply for this job: International PV Audit and Compliance Manager

Contact Information:

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

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