Assoc MDR Vigilance Specialist | Hybrid

Our client a major multinational based here in Galway are 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

• 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.