Adverse Event Reporting escalates risks, delays, or potential compliance concerns to management in a timely manner. Supports AER/MDR review meetings or committees by preparing agendas, compiling records for review, documenting decisions and action items, tracking owners and due dates, and maintaining meeting minutes or related evidence. Assists with monthly metrics, dashboards, trend summaries, late-report reviews, reportability volumes, submission status, product line summaries, region summaries, and other management reporting related to AER/MDR-vigilance performance. Supports audit, inspection, CAPA, nonconformance, remediation, and continuous-improvement activities related to adverse event reporting, complaint reportability, regulatory submissions, documentation quality, and process effectiveness. Maintains awareness of applicable medical device reporting and vigilance requirements, internal procedures, work instructions, process changes, and training expectations relevant to assigned responsibilities. May assist with urgent or time-sensitive AER/MDR-vigilance activities outside normal business hours based on business need and management direction. Performs duties of the Senior Adverse Event Reporting experience with eQMS, complaint management systems, electronic MDR/vigilance submission tools, ERP, Windchill, SAP, or data reporting systems preferred. Demonstrated ability to follow procedures and work instructions, identify documentation gaps, support problem solving, and contribute to continuous improvement of AER/MDR-vigilance screening, reporting, monitoring, and closure processes. -Or- An equivalent competency level acquired through a variation of these qualifications may be considered. Additional Information May require domestic or international travel based on business needs. If you're ready to make a significant impact in a dynamic and collaborative environment, we invite you to apply for this exciting opportunity. Please submit your CV viaour Terumo BCT careers portal mySource before the closing date of 5pm Wednesday, 4th November 2026. You must clearly demonstrate on your CV / application how you meet the required criteria as failure to do so may result in you not being shortlisted. Join us in driving progress and supporting patients locally and across the globe every day by Contributing to Society Through Healthcare! Benefits: Attractive Salary Performance Bonus Pension Plan Private Healthcare Income Protection Life Assurance WHJS1_NI
Adverse Event Reporting Global Vigilance Specialist employer: Terumo BCT Ltd
Terumo BCT Ltd is an exceptional employer located in Larne, offering a dynamic work environment where employees can thrive while contributing to meaningful healthcare solutions. With a strong focus on employee growth, the company provides comprehensive training and development opportunities, alongside a supportive culture that promotes safety and compliance. Employees enjoy attractive benefits such as private health care, performance bonuses, and a robust pension plan, making it a rewarding place to build a career in the pharmaceutical industry.
