Vigilance Reporting Specialist

Philips•Bothell, WA

3d•Hybrid

About The Position

In this role you You are responsible for investigating and resolving complex complaints, ensuring accurate documentation and analysis, establishing follow-up measures, enforcing coding standards, leading complaint investigations and responses, collaborating cross-functionally for technical investigations, and training new complaint operations investigators.

Requirements

Bachelor's / Master's Degree in Medical Sciences, Healthcare Management, Industrial Engineering, Supply Chain Management or equivalent.
3+ years of experience with Bachelor's in areas such as Medical Device, Quality Assurance, Quality Control, Clinical Research or equivalent
3+ years of experience with Post Market, Vigilance Reporting in medical device.
Experience in Quality System, CAPA, Reliability, Root Cause investigation concepts and tools, etc.
Must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this Office/Remote position.

Responsibilities

Investigates and resolves highly complex complaints by monitoring product analysis findings or service analysis notes, documents underlying issues, and ensures the implementation of solutions to address customer concerns efficiently.
Enforces standards for appropriate coding to records as input for the complaints process, coordinates requests for new coding, when necessary, ensures all systems and tools are updated, and reviews and updates complaints as new codes become available.
Heads the end-to-end investigation of complaints, including condensing pertinent information, analyzing findings, and presenting a concise overview of the inquiry process, including key issues identified, evidence gathered, and resolutions proposed or implemented.
Leads customer response letters (CRL) or internal responses, as appropriate, upon concluding the investigation, utilizes effective communication and problem-solving skills, and escalates complex matters to appropriate channels for further assistance and resolution.
Performs the training and qualification of new PMS complaint operations investigators, provides guidance, resources, and hands-on instruction to facilitate their understanding of complaint handling processes, regulatory requirements, and best practices.