Vigilance Reporting Specialist

About the role

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.

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.
• Led 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.

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.

Qualifications

The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity. In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered.

Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more.

Benefits

Details about our benefits can be found here.

Pay

The pay range for this position in Bothell, WA is $102,000 to $143,000 Annually.

Schedule

This is an office role.

Company

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve.