CroíValve are looking for a Clinical Safety Specialist to support activities related to global clinical trial execution of a cutting-edge structural heart device. 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 our Dublin office.Key Responsibilities and DutiesReview, evaluation of, and tracking of incoming adverse events (AEs) including follow-up of ongoing events.Collaboration with sites, monitors, and Contract Research Organization (CRO) to ensure comprehensive information is available for full review of adverse events.Preparation of event narratives to facilitate the adjudication and reporting process.Liaison for clinical sites and cross-functional team members on all aspects of safety monitoring.Verification of consistency and compliance in application of protocol definitions for adjudication outcomes.Providing input to the development and management of study related documents including clinical protocols, case report forms, monitoring plans, study manuals, and other study tools related to adverse event reporting and definitions.Preparation of safety reporting for annual reports, clinical study reports, investigator brochure updates, and other documents as required.Development and maintenance of study-specific Safety Management Plans including event narrative and adjudication templates.Assist in training of study personnel regarding the adverse event definitions per protocolAssist in the management of the Clinical Events Committee(s) and Data Safety Monitoring Board(s).Assist in maintenance of the electronic database and clinical data structure ensuring update to data and accurate information is readily available.Communicate the study status and timelines and escalate unresolved issues appropriately to line manager.Maintain knowledge of current FDA, ISO, competent authority, IRB, REB, and EC regulatory rules and policies affecting AE reporting.Support trial/regional enrolment strategy and execution.Support management of essential documents and Trial Master File, ensuring inspection-readiness. Identify and assist in developing continuous improvement activities.Ensure interactions with colleagues/stakeholders fully reflects the company values.Company ValuesOne team working together to ensure the whole is greater than the sum of the partsPersonal Ownership: deliver on commitmentsOpen Communication: Honest open-minded communicationFun: celebrate the successesContinuous Learning: at an individual and company levelSolution Orientated: Identify problems but focus your energy on solutionsQuality Focused: patient safety comes firstEssential RequirementsTechnical: Fundamental understanding and frequent application of quality principles for medical devices, ideally class III implantable devices. Knowledge of key Good Clinical Practice and Regulatory standards and their application.Problem Solving: Supports a culture of data-driven problem solving that ensure development of high-quality devices. This includes adherence to any systems / processes for robust data capture, analysis and presentation of information to guide the decision-making process.Project Management: Demonstrates project management & organisational skills. Ability to complete individual tasks on time.Initiative: Demonstrated ability to take initiative to prioritize work, reach business objectives and challenge task team decisions as required.People Skills: Demonstrates people skills to work effectively with others to achieve company goals.Communication: Effective verbal and written technical communication skills of technical information in a format appropriate for the understanding of others. Demonstrated effective presentation and group communication skills.Education and ExperienceDegree or master's degree in science or engineering, or related disciplinesMinimum 2+ years' experience in clinical safety or combined clinical safety/post-market vigilance experience, with prior clinical research experience preferredExperience in cardiovascular disease preferredExperience with class III medical device clinical studies preferredExpertise with medical device regulations and compliance guidelines for clinical studies including ISO 14155, 21 CFR 812, EU MDR and other relevant guidance documentsExcellent communication, organisational and time management skillsAvailability to travel is required