Associate MDR/Vigilance Specialist
Responsibilities
1. Monitors the company's drug or medical devices surveillance program including the intake, protocol development, evaluation, processing, and follow-up on adverse reports.
2. Participates in the resolution of any legal liability and ensures compliance with government regulations.
3. 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.
4. Reviews and analyzes clinical databases for the extraction of ADE data and integrates the data to ensure the creation of a unified database.
5. Supports ADE standardization and internalization to ensure accuracy and quality of safety summaries.
6. Acts as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements.
7. Delivers and/or manages assigned projects and works with stakeholders to achieve desired results.
8. May mentor colleagues or direct the work of lower-level professionals.
9. Focuses primarily on delivering and overseeing projects from design to implementation while adhering to policies and using specialized knowledge.
Requirements
10. Entry-level individual contributor with responsibility in a professional discipline or specialty.
11. Works with close supervision.
12. Delivers work of limited scope, typically on smaller and less complex projects.
13. Identifies and addresses problems that are typically not difficult or complex; makes minor changes to systems and processes.
14. Communicates primarily with internal contacts within the immediate group to gather, confirm, and convey information.
15. Focuses on self-development; no leadership or talent management responsibilities at this level.
16. Requires broad theoretical job knowledge, typically obtained through advanced education.