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.
- 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.
For more information or to apply for this Senior Biostatistician position, please contact Stephanie Maccioni on 01438 768713 or email email@example.com, quoting job ref 48903.
It is essential that applicants hold entitlement to work in the UK.