Our client, a major multinational based here in Galway, is looking to hire an Assoc MDR Vigilance Specialist on an initial 12-month contract.
This is a Hybrid role - 2 days in the office per week.
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 by regulatory agencies.
* 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.
Requirements:
* Bachelor's degree (Level 8 NFQ) in Engineering/ Science/ Legal/ Clinical or related discipline.
* 1-2 years relevant experience in a medical devices or related environment preferred.
* Dynamic team player who can work effectively and proactively on cross-functional teams.
* Ability to think critically and make sound decisions.
* Strong attention to detail.
* Knowledge of basic anatomy, physiology, and medical terminology.
* Must be focused on patient safety and customer service, set high standards, instill operational excellence, drive accountability and model ethical behavior.
* Good communicator and fluent in English, both in writing and speaking.
For more information and a confidential discussion on the role, please contact Michelle Mc Inerney.
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