Associate MDR/Vigilance Specialist

Associate MDR/Vigilance Specialist
12 month contract 
Hybrid - Galway 

Key Responsibilities

Responsibilities may include the following and other duties as assigned:

• Monitors the company's drug or medical device surveillance programme, including the intake, protocol development, evaluation, processing and follow-up of adverse event reports.
• Participates in the resolution of potential legal liability matters and ensures compliance with applicable government regulations.
• Ensures the complete and accurate maintenance and reporting of Medical Device Reports (MDRs), Adverse Drug Experience (ADE) data and adverse reaction data, as required by regulatory agencies.
• Reviews and analyses clinical databases to extract ADE data and integrates information to establish a unified database.
• Ensures databases are consistent with the objectives of ADE standardisation and internalisation, while maintaining the accuracy and quality of safety summaries.
• Acts as a liaison with internal teams and external collaborators to develop programmes and processes that meet regulatory reporting requirements.

Specialist Career Stream

Typically an individual contributor with responsibility within a professional discipline or specialty.

• Delivers and/or manages assigned projects, working collaboratively with stakeholders to achieve desired results.
• May act as a mentor to colleagues or direct the work of other lower-level professionals.
• Spends the majority of their time delivering and overseeing projects from design through to implementation.
• Works in accordance with established policies, applying specialised knowledge and skills normally acquired through advanced education.

Differentiating Factors

1. Autonomy

• Entry-level individual contributor working on a project or within a team.
• Works under close supervision.

2. Organisational Impact

• Delivers work of limited scope, typically involving smaller, less complex projects or related activities.

3. Innovation and Complexity

• Identifies, defines and addresses problems that are not immediately evident but are generally not difficult or complex.
• Makes minor changes to systems and processes to resolve problems.

4. Communication and Influence

• Communicates primarily with internal contacts within the immediate team.
• Contacts others to gather, confirm and communicate information.

5. Leadership and Talent Management

• Not applicable. Roles at this level are focused on individual development.

Required Knowledge and Experience

• Requires broad theoretical job knowledge, typically obtained through advanced education.
• Requires a Bachelor's degree (or, for degrees earned outside the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A)).
• No previous professional experience required (0 years).