Job Description
The Role PE Global are recruiting for an Associate MDR/Vigilance Specialist - Galway for our medical device client based in Galway. This is a 12-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. Education & Experience Bachelors 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 Interested candidates should submit an updated CV. Please click the link below to apply, alternatively send an up-to-date CV ****Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland**** Although it is not possible for us to respond to all applications, we at PE Global will do our upmost to give you feedback on your application. You have sent your Cv into us as a company and even though you have sent your CV to a particular position, we are making the reasonable assumption that you are active on the job market and as part of our normal recruitment service we will discuss other suitable positions with you. You are free to opt out of this so please specify in your application to us if you just want to be contacted in relation to a specific vacancy. Your Cv is sent to a central recruitment inbox which a number of people in the applicable PE Global division have access to and so this means that you might not be contacted by the named person in this advert. Skills: MS Office Suite Medical Device Medical Reporting Science Engineering