Responsibilities:

• Monitor the company's drug or medical device surveillance program, overseeing intake, protocol development, evaluation, processing, and follow-up on adverse reports.

• Participate in the resolution of legal liabilities and ensure compliance with government regulations.

• Ensure accurate maintenance and reporting of Medical Device Reports (MDRs) and Adverse Drug Experience (ADE) data as required by regulatory agencies.

• Review and analyze clinical databases to extract ADE data, integrating it into a unified database to standardize and internalize safety summaries.

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

Differentiating Factors:

• Autonomy: Entry-level individual contributor working with close supervision.

• Organisational Impact: Deliver work of limited scope, such as smaller, less complex projects.

• Innovation and Complexity: Identify and address problems, making minor system and process changes.

• Communication and Influence: Primarily communicate within immediate group, gathering and conveying information as needed.

Required Knowledge and Experience:

• Requires broad theoretical knowledge typically acquired through advanced education.

• Bachelors degree required (or equivalent for degrees earned outside the Republic of Ireland), with 0 years of experience.