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
Requirements
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 *****, 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
For more information, please contact Sinéad Cullen on ************* or ******
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