Associate MDR/Vigilance Specialist
Responsibilities
- Monitors the company's drug or medical devices surveillance program including the intake, protocol development, evaluation, processing, and follow-up on adverse reports.
- Participates in the resolution of any legal liability and ensures compliance with government regulations.
- Ensures complete and accurate maintenance and reporting of Medical Device Reports (MDRs), Adverse Drug Experience (ADE) data, or adverse reaction data as required by regulatory agencies.
- Reviews and analyzes clinical databases for the extraction of ADE data and integrates the data to ensure the creation of a unified database.
- Supports ADE standardization and internalization to ensure accuracy and quality of safety summaries.
- Acts as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements.
- Delivers and/or manages assigned projects and works with stakeholders to achieve desired results.
- May mentor colleagues or direct the work of lower-level professionals.
- Focuses primarily on delivering and overseeing projects from design to implementation while adhering to policies and using specialized knowledge.
Requirements
- Entry-level individual contributor with responsibility in a professional discipline or specialty.
- Works with close supervision.
- Delivers work of limited scope, typically on smaller and less complex projects.
- Identifies and addresses problems that are typically not difficult or complex; makes minor changes to systems and processes.
- Communicates primarily with internal contacts within the immediate group to gather, confirm, and convey information.
- Focuses on self-development; no leadership or talent management responsibilities at this level.
- Requires broad theoretical job knowledge, typically obtained through advanced education.
