Associate MDR & Vigilance Specialist

• 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.

• 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.

Cpl Group