Associate MDR Vigilance Specialist
Galway, County Galway, Ireland · Contract
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- Experience
- Any
- Salary
- —
- Openings
- 1
- Posted
- منذ 3 ساعات
- Work mode
- In office
- Education
- Bachelor's degree
- Resume
- Required to apply
Where you'll work
Job description
About the Employer
Become part of a forward-thinking organization committed to advancing drug and medical device safety. You will contribute to patient safety through rigorous surveillance and adherence to international regulatory standards. The company fosters a culture of integrity, professional development, and expertise enhancement.
Role Overview
In the role of Safety Surveillance Specialist, your duties will include monitoring drug and medical device safety surveillance programs. This encompasses protocol creation, thorough evaluation, intake, processing, and follow-up on reports of adverse events. You will ensure precise documentation and submission of Medical Device Reports (MDRs) and Adverse Drug Experience (ADE) data according to regulatory mandates.
Your responsibilities also involve analyzing clinical databases to extract ADE data, ensuring its integration and standardization to produce cohesive safety summaries. In addition, you will collaborate internally and externally to develop and uphold effective reporting processes and programs. Participation in resolving legal liabilities and supporting government compliance efforts is expected. You will manage project tasks from conception through deployment, often working within a supervised team environment.
Qualifications and Skills Required
- A Bachelor’s degree or an equivalent international qualification in line with regulatory standards.
- Extensive foundational knowledge of drug or device safety, commonly obtained through advanced academic study.
- Proficiency in data analysis and database management, with meticulous attention to detail and accuracy.
- Strong communication abilities to facilitate effective teamwork.
- Flexibility in adapting to well-defined tasks and a drive towards professional skill enhancement.
Benefits and Opportunities
- Attractive salary package.
- Comprehensive training and continuous professional growth initiatives.
- Practical exposure to a critical and heavily regulated healthcare sector.