Clinical Safety Specialist
Our client, medical device organisation, are currently recruiting for a Clinical Safety Specialist to support activities related to global clinical trials. This role ensures all aspects of safety are conducted according to procedure and in a compliant manner. This is a hybrid role based out of Dublin.

Responsibilities

• Review, evaluate, and track incoming adverse events (AEs) including follow-up of ongoing events
• Collaborate with sites, monitors, and Contract Research Organizations (CROs) to ensure complete AE information is available for review
• Prepare event narratives to facilitate adjudication and reporting
• Act as liaison for clinical sites and cross-functional teams on safety monitoring
• Verify consistency and compliance in the application of protocol definitions for adjudication outcomes
• Provide input to the development and management of study documents (protocols, case report forms, monitoring plans, manuals, and other tools)
• Prepare safety reporting for annual reports, clinical study reports, investigator brochure updates, and other regulatory documents
• Develop and maintain study-specific Safety Management Plans, including event narrative and adjudication templates
• Assist in training study personnel on AE definitions per protocol
• Support the management of Clinical Events Committees and Data Safety Monitoring Boards
• Maintain the electronic database and clinical data structure for accurate, up-to-date information
• Communicate study status and timelines; escalate unresolved issues appropriately
• Maintain knowledge of FDA, ISO, competent authority, IRB/REB, and EC regulatory rules affecting AE reporting
• Support trial/regional enrollment strategy and execution
• Manage essential documents and Trial Master File, ensuring inspection readiness and continuous improvement activities

• Degree or master’s degree in science, engineering, or related disciplines
• Minimum 2+ years’ experience in clinical safety or combined clinical safety/post-market vigilance, clinical research experience preferred
• Experience in cardiovascular disease preferred
• Experience with Class III medical device clinical studies preferred
• Expertise with medical device regulations and compliance guidelines (ISO 14155, 21 CFR 812, EU MDR, and other relevant guidance)
• Understanding and frequent application of quality principles for medical devices, ideally Class III implantables. Knowledge of Good Clinical Practice and regulatory standards
• Excellent communication, organizational, and time-management skills
• Supports data-driven decision-making and high-quality device development
• Demonstrates strong organizational and task management skills
• Ability to prioritize work, reach objectives, and challenge team decisions when appropriate
• Works effectively with others to achieve company goals
• Effective verbal and written technical communication, including presentations.
• Ability to travel