Associate MDR/Vigilance Specialist Role
We are recruiting for a highly skilled Associate MDR/Vigilance Specialist to join our team at PE Global. This is a 24-month contract role with hybrid working options.
Key Responsibilities:
* Monitor the company's drug or medical devices surveillance program, including intake, protocol development, evaluation, processing, and follow-up on adverse reports.
* Participate in the resolution of legal liability and compliance with government regulations.
* Ensure accurate maintenance and reporting of Medical Device Reports (MDRs), Adverse Drug Experience (ADE) data, or adverse reaction data as required.
* Review and analyze clinical databases for the extraction of ADE data and integrate it into a unified database.
* Act as a liaison internally and externally to develop programs and processes that meet regulatory reporting requirements.
* Deliver and manage projects assigned, working with stakeholders to achieve desired results.
* Ensure the highest quality of product event data entry for accuracy of reporting to regulatory agencies.
* Identify and address problems, making minor changes in systems and processes to solve them.
Requirements:
* Bachelor's degree in Engineering/Science or related discipline or candidates with a legal or clinical qualification.
* Entry-level individual contributor on a project or work team, working with close supervision.
* Good attention to detail, organizational, and communication skills.
Working Environment:
* Hybrid working options available.
Additional Information:
* Candidates must have the correct visa to live and work in Ireland.
Skills:
* MS Office Suite
* MDR Reg Affairs
* Science
* Med Device control systems