Associate MDR & Vigilance Specialist
Location: Parkmore, Galway
Duration: 24 Months
Job Type: Onsite

Position Overview

The Associate MDR & Vigilance Specialist monitors and manages adverse event reporting for medical devices and/or drugs, ensuring compliance with regulatory requirements. The role involves analyzing clinical data, maintaining safety reports, and collaborating internally and externally to support vigilance programs.

Key Responsibilities

• Monitor the company’s drug or medical device surveillance program, including:

  • Intake, protocol development, evaluation, and follow-up on adverse reports

  • Participation in resolving any legal liability issues

  • Compliance with government regulations

• Ensure complete and accurate maintenance and reporting of:

  • Medical Device Reports (MDRs)

  • Adverse Drug Experiences (ADEs)

  • Adverse reaction data as required by regulatory agencies

• Review and analyze clinical databases to extract ADE data, integrating it to create a unified database consistent with ADE standardization and internalization

• Ensure accuracy and quality of safety summaries

• Act as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements

Specialist Career Stream

• Individual contributor with responsibility in a professional discipline or specialty

• Delivers and/or manages assigned projects, working with stakeholders to achieve results

• May mentor colleagues or direct work of lower-level professionals

• Majority of time spent delivering and overseeing projects from design to implementation, adhering to policies and applying specialized knowledge

Differentiating Factors

• Autonomy: Entry-level individual contributor on a project or work team; works with close supervision

• Organizational Impact: Work of limited scope; typically smaller, less complex projects or related activities

• Innovation & Complexity: Identifies minor problems and makes small process or system changes

• Communication & Influence: Primarily communicates with internal contacts within immediate group; contacts others to gather, confirm, and convey information

Required Knowledge & Experience

• Broad theoretical job knowledge, typically obtained through advanced education

• Relevant degree required

• 1–2 years of experience in a similar field