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
#J-*****-Ljbffr