Safety Lead

  • Salary: £80,000 - £100,000
  • REF Number: 00048903
  • Consultant: Stephanie Maccioni
  • Contact: 01438 870022
  • Date Published: 19.10.2020
  • Sector:
  • Location: Hertfordshire, Home Counties
  • Discipline:

CK Clinical are recruiting for a Safety Lead to join a join a very well respected Global Pharmaceutical based in Hertfordshire, this role is site based with some flexible home working.

Principal responsibilities will include to:

  • Be accountablefor ensuring oversight of affiliate compliance with Pharmacovigilance (PV) legislation.
  • Fulfils the role of Local Safety Responsible (LSR) for the UK & assigned territories of Gibraltar and Falkland Islands.
  • Maintains oversight of safety riskmanagement and all other pharmacovigilance (PV) activities.
  • Liaises with external professional bodies to bring strategic insights and contributes to shaping the future PV requirements.
  • Ensure appropriate prioritisation, oversight & resource allocation to meet expected regulatory requirements and to ensure compliance with global and local regulatory requirements for all areas of responsibility
  • Dotted reporting line into the global head of International Pharmacovigilance via the Country Cluster Lead.

Requirements:

  • Experience practicing medicine with a GMC registered physician with a "License to Practice" preferred.
  • Significant experience in safety & pharmacovigilance (advanced level of experience) with additional experiencein Clinical Research and /or Medical Affairs highly desirable.
  • Extensive knowledge of regulatory requirements (UK and EU).
  • Substantial leadership experience in Pharmaceutical or Biotech industry required.

Full job description available upon request.

Apply:

For more information or to apply for this Senior Biostatistician position, please contact Stephanie Maccioni on 01438 768713 or email smaccioni@ckgroup.co.uk, quoting job ref 48903.

It is essential that applicants hold entitlement to work in the UK.

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