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Senior Clinical Safety Specialist

1 month ago

Cambridge, Cambridgeshire, United Kingdom CK Group Full time £100
Senior Clinical Safety Specialist Job Description

CK Group is looking for a highly experienced Clinical Safety Scientist to lead all clinical safety activities for a clinical-stage biotech on a contractual basis.

  • This Associate Director level role will involve managing safety within the clinical study teams, providing input to the design and preparation of protocols, investigators brochures, informed consent forms, and investigator notification letters.
  • The ideal candidate will have significant experience in clinical safety and a solid working knowledge of relevant regulations (e.g. FDA, EU and ICH).

Salary: £120,000 per year

Location: 4 days remote, 1 day on-site

Responsibilities
  • Manage safety evaluation activities, including First in Human (FIH) studies.
  • Carry out regular review of emerging safety data and present important safety issues to senior management, other internal and external stakeholders.
  • Author aggregate safety assessments and drug safety reports for signals/issues or in response to Regulatory Authority requests.
  • Coordinate and collaborate with external vendors.
Your Background
  • Significant experience in clinical safety.
  • Excellent knowledge of all phases from first in man to post approval.
  • Solid working knowledge of relevant regulations.
  • Previous experience of managing clinical safety activities for multiple programmes.
  • Hands-on understanding of MedDRA.