EDUCATION & EXPERIENCE

• Bachelor’s degree (Level 8 NFQ) in Engineering/Science or related discipline or candidates with a legal or clinical qualification.
• Entry-level individual contributor on a project or work team. Works with close supervision.
• Good attention to detail, organisational and communication skills

THE ROLE

PE Global are recruiting for an Associate MDR/Vigilance Specialist for our medical device client based in Galway. This is a 24-month contract role. Hybrid working options.

JOB RESPONSIBILITIES

• Monitors the company’s drug or medical devices surveillance program including the intake, protocol development, evaluation, processing, and follow-up on adverse reports
• Participation in the resolution of any legal liability and in complying with government regulations.
• Ensures complete and accurate maintenance and reporting of Medical Device Reports (MDRs), Adverse Drug Experience (ADE) data or adverse reaction data as required.
• Review and analyse clinical databases for the extraction of ADE data and integrates the data to ensure the creation of a unified database consistent with the aims and purposes of ADE standardization and internalization as well as to ensure the accuracy and quality of safety summaries.
• Acts as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements.
• Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results.
• Majority of time is spent delivering and overseeing the projects – from design to implementation - while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education.
• Ensure highest quality of product event data entry for accuracy of reporting to regulatory agencies.
• Identifies, defines and addresses problems that are not immediately evident but typically not difficult or complex. Makes minor changes in systems and processes to solve problems.
• Communicates primarily with internal contacts within immediate group. Contacts others to gather, confirm and convey information.