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Sinead Cullen
Life Science

01 507 9252
[email protected]
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Details

Clinical Safety Specialist


Reference:SCA015579 Location: Dublin
Qualification:DegreeExperience:2-3 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Clinical Project Manager, Clinical Research Associate, Clinical Research Nurse, Clinical Trials Advisor, Clinical Trials Assistant

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 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
For more information, please contact Sinéad Cullen on +353879500821 or [email protected]