Julia Day at the CK Group is looking for an experienced, Clinical Safety professional, to join a clinical-stage biotech on a contractual basis.
This is an Associate Director level role, you will lead all clinical safety activities for your assigned compound.
Contract length – 6 months.
Location – 4 days a week from home, 1 day a week on-site.
Rate – Circa £100 per hour.
Responsibilities – not limited to: Manage safety within the clinical study teams, providing input to the design and preparation of protocols, investigators brochures, informed consent forms and investigator notification letters.
Mange safety evaluation activities including First in Human (FIH) studies.
Carry out the regular review of emerging safety data and presenting important safety issues to senior management, other internal and external stakeholders (e.g Safety Monitoring Committee, Independent Data Safety Monitoring Boards).
Authoring and/or review of 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 (e.g.
ad-hoc queries, DSURs, PBRERs and RMPs).
Responsible for coordination and collaboration 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 (e.g.
FDA, EU and ICH).
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 for patients.
Apply: Please contact Julia Day on 01246 457719, ****** for more information.
Alternatively, click "Apply" below. Please quote job reference 108 065 in all correspondence.