Vigilance Reporting Specialist
Philips
Summary
You are responsible for meticulously investigating and assisting in resolving highly complex complaints, leading comprehensive investigations, overseeing complaint records, analyzing data for potential product enhancements, ensuring regulatory compliance, and supporting the training of new investigators in complaint handling processes and regulatory standards.
Job description
Your role:
- 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.
You're the right fit if:
- 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 with vocational education.
- Prefer experience with Post Market Complaint Handling, Vigilance Reporting in medical device and/or experience as a team lead in a complaint handling capacity.
- You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this Office/Remote position.
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 with vocational education.
- Prefer experience with Post Market Complaint Handling, Vigilance Reporting in medical device and/or experience as a team lead in a complaint handling capacity.
- You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this Office/Remote position.
Benefits
- Paid Time Off
- 401(k) With Up to 7% Match
- Health Savings Account With Company Contribution
- Stock Purchase Plan
- Education Reimbursement
- Annual Incentive Bonus
- Sales Commission
- Long-Term Incentives
Company overview
Koninklijke Philips N.V., commonly known as Philips, is a Dutch multinational health technology company that has evolved from its origins as a consumer electronics conglomerate into a leading global healthcare solutions provider. Founded in 1891 in Eindhoven, Netherlands, Philips has transformed its business focus since the 2010s to concentrate exclusively on health technology. The company operates through three main divisions: Diagnosis and Treatment, which manufactures advanced medical imaging equipment including MRI, CT, and ultrasound scanners; Connected Care, specializing in patient monitoring systems and respiratory care products under the Respironics brand; and Personal Health, producing consumer healthcare products like electric shavers, Sonicare toothbrushes, and Avent childcare items. With 68,419 employees worldwide and annual revenues of €18.02 billion (2024), Philips maintains its global headquarters in Amsterdam while operating manufacturing, R&D, and sales facilities across 26 countries. The company has strategically divested its consumer electronics, lighting, and home appliance businesses to become a pure-play health technology organization, positioning itself at the forefront of medical innovation and digital healthcare solutions.