Clinical Safety Expert

6 days ago


Cambridge, Cambridgeshire, United Kingdom CK Group Full time £100

We are seeking an experienced Clinical Safety professional to join our team at the CK Group on a contractual basis. This Associate Director level role will lead all clinical safety activities for assigned compounds.

About the Role

As a key member of the clinical study teams, you will provide input to the design and preparation of protocols, investigators brochures, informed consent forms, and investigator notification letters.

  • Manage safety evaluation activities including First in Human (FIH) studies.
  • Carry out regular reviews of emerging safety data and present important safety issues to senior management, other internal and external stakeholders.
  • Author or review aggregate safety assessments and drug safety reports for signals/issues or in response to Regulatory Authority requests.

This is an excellent opportunity to contribute to and summarize safety data effectively for use in regulatory or clinical trial documents.

Requirements

You will need significant experience in clinical safety, excellent knowledge of all phases from first in man to post-approval, and previous experience managing clinical safety activities for multiple programmes.

The ideal candidate will have strong communication and interpersonal skills, with the ability to work effectively in a fast-paced environment.

Acirca £100 per hour, this is a fantastic opportunity to bring your expertise to a leading biotech company.



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