The Role
PE Global are recruiting for an
Associate MDR/Vigilance Specialist
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
* 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
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****