Clinical Safety Director
21 hours ago
CK Group is seeking an experienced Clinical Safety Scientist to lead clinical safety activities for a clinical-stage biotech on a contractual basis.
- Contract Length: 6 months
- Location: 4 days a week from home, 1 day a week on-site
- Rate: Circa £100 per hour
Responsibilities:
- Manage safety within clinical study teams, providing 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.
- Conduct regular review of emerging safety data and present important safety issues to senior management, other internal and external stakeholders.
- Author and/or review aggregate safety assessments and drug safety reports for signals/issues or in response to Regulatory Authority requests.
- Contribute to and summarize safety data effectively for use in regulatory or clinical trial documents.
- Responsible for coordination and collaboration with external vendors.
- 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 the MedDRA.
- Willingness to challenge and be challenged to ensure optimal decision making and delivery of solutions.
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