Head of Quality, Regulatory and PV

  • Salary: Competitive
  • REF Number: 00030002
  • Consultant: Jim Gleeson
  • Contact: 01438 842973
  • Date Published: 13.06.2014
  • Closed Date: 24.08.2015
  • Sector: Oncology
  • Location: London
  • Discipline: Clinical Quality Assurance, Drug Safety And Pharmacovigilance

A Head of Quality, Regulatory and Pharmacovigilance is required for a permanent role with a leading healthcare charity, based at their offices in London.

Responsibilities:

As Head of Quality, Regulatory and Pharmacovigilance you will lead a multidisciplinary team covering the Quality Assurance, Pharmacovigilance, Regulatory Affairs, Medical Writing and Training functions, ensuring high performance and engendering a culture of continuous improvement, scientific excellence and staff development

Key duties will include:

  • Management of the team budget and resources
  • Overall responsibility for the QMS, including controlled documents, audit programme and metrics review
  • Ensuring all trials are conducted to appropriate EU and UK regulatory and quality standards
  • Overall responsibility for the pharmacovigilance system, delivering compliant ISCR processing and submission, effective safety review and DSUR writing
  • Management of the regulatory affairs function, ensuring that regulatory intelligence is carried out and the Clinical Trial Applications and Protocol Amendments are delivered as planned
  • Oversight of medical writing, delivering ICH compliant Clinical Study Reports and Investigator Brochures
  • Oversight of the training function to assess and deliver the training needs of an early phase group including GCP and inspection readiness training

Qualifications: As Head of Quality, Regulatory and Pharmacovigilance, you will require the following:

  • Expertise in ICH Good Clinical Practice
  • Good knowledge of Pharmacovigilance, Medical Writing and Training
  • Ability to lead and manage multidisciplinary teams and technical experts
  • An excellent knowledge of the current legislation pertaining to clinical trials and pharmacovigilance in the UK

For more information or to apply for this Head of Quality, Regulatory and Pharmacovigilance position please contact Jim Gleeson on +44 (0)1438 842973 or email jgleeson@ckclinical.co.uk. Alternatively, please click on the link below to apply online now.

CK Clinical is an Equal Opportunities employer and welcomes applications from all who meet our selection.

If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL30002 in all correspondence.

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