Associate Director, Clinical Safety Scientist
1 week ago
Job Title: Associate Director - Clinical Safety We are seeking an experienced Clinical Safety professional to join our team on a contractual basis.
Contract Length: 6 months Remote Work Option: 4 days a week from home, 1 day a week on-site in [Location] Hourly Rate: Circa £100 per hour Key Responsibilities: Manage safety within clinical study teams, providing input to protocol design and preparation, investigators brochures, informed consent forms, and investigator notification letters.
Lead safety evaluation activities including First-in-Human studies.
Regularly review emerging safety data and present important safety issues to senior management, internal, and external stakeholders.
Author or review aggregate safety assessments and drug safety reports for signals or Regulatory Authority requests.
Contribute to summarizing safety data effectively for regulatory or clinical trial documents.
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 (FDA, EU, ICH).
Previous experience managing clinical safety activities for multiple programs.
Hands-on understanding of MedDRA.
Willingsness to challenge and be challenged to ensure optimal decision-making and delivery of solutions for patients.
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