Safety Lead
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.
CLINGEN
