Clinical Safety Manager

My client a leading global CRO are looking for a Clinical Safety Manager to join their diverse, collaborative and inclusive Safety team. The Clinical Safety Manager will lead & contribute to the ongoing co-ordination of Safety activities for assigned projects covering diverse therapeutic areas Across multiple developmental stages. If you are an experienced Safety professional, please read below…

Responsibilities

• Coordination and tracking of serious adverse event reporting, study report narratives, reconciliation of documentation, call center function and requests for follow-up information for multiple projects/studies;
• Coordinate Regulatory Agency case report submission and case report distribution (internal and external) as appropriate
• Generate periodic and annual safety reports
• Effectively manage distribution of expedited, periodic, and annual reports to Regulatory Agencies, Ethic's Committees, and sites in accurate and timely fashion
• Report adverse events to regulatory authorities as required
• Provide safety review of clinical study documentation, including protocols, study reports, and marketing application components
• Finalize all Clinical Safety documents, including safety plans, case reports, Investigator Safety Letters, and narratives
• Lead Clinical Safety activities for multiple trials and Sponsors
• Project-specific oversight of Clinical Safety Coordinators and Project Assistants;
• Provide safety advice and guidance to Clinical Operations including review of protocols, study reports, and marketing application components
• Provide/propose development specifications for new projects

Requirements

• Master’s degree and 3 years of clinical safety experience, or Bachelor’s degree and 5 years of clinical safety experience
• Demonstrate comprehensive knowledge of global safety regulatory requirements
• Demonstrable experience of write departmental SOPs
• Be comfortable in a client facing role
• Ability to train and develop junior team members

If you are interested, get in touch with me ASAP…