Head of Drug Safety & Quality

  • Salary: Competitive
  • REF Number: 00036008
  • Consultant: Julia Day
  • Contact: 01246 457719
  • Date Published: 24.05.2016
  • Closed Date: 07.09.2016
  • Sector:
  • Location: Hertfordshire,
  • Discipline:

Julia Day at CK Clinical is looking for an experienced GMC Registered Physician with experience of managing drug safety functions. This role will hold over 20 reports; 4 direct and the rest second line; across the safety and quality functions.

  • The role also involves responsibility for pharmacovigilance compliance and safety oversight across the affiliate as the UK Local Safety Responsible.
  • Be the external company face in the UK for PV related issues including interactions with the MHRA, inspections etc. as well as taking the lead in interactions with the global organisation in matters of pharmacovigilance and quality.
  • You will ensure high compliance & quality standards for GVP & Quality Assurance across all areas, and ensure adequate resourcing of these critical areas.
  • You will keep an overview of a broad spectrum of activity across many areas of the business, including clinical trials, market research & patient support programmes.
  • You will also assume responsibility for safety training as the subject matter expert across the UK company.
  • Your group is closely involved with the local implementation of Risk Management Planning, safety label updates and aggregate reporting.
  • Help develop and implement the strategy and tactics for the UK Medical Directorate, beyond just safety.
  • Manage the budget and resource planning.

Requirements:

  • A GMC registered physician with a licence to practice, along with experience within Safety and Pharmacovigilance.
  • Experience within Medical Affairs would also be a benefit, but not a requirement.
  • You will have demonstrable previous line management experience or group leadership skills and experience.
  • You must also be confident in influencing and engaging with both internal and external stakeholders, including MHRA.

For further information please contact Julia Day at jday@ckclinical.co.uk or 01246 457 719. 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 criteria.

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 CL36008 in all correspondence.

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