Vigilance Reporting Specialist

Philips; Plymouth (MN); Sur place; USD 67 000 - 93 000; Plein temps

Avantages offerts par ce poste

PTO

401k match

HSA contributions

Stock purchase plan

Education reimbursement

Résumé du poste

Philips is seeking a Vigilance Reporting Specialist to lead complex complaint investigations, ensure regulatory compliance, and drive data-driven product improvements in Plymouth, MN. You will manage end-to-end investigations, prepare concise summaries, and coach new investigators on complaint handling processes and regulatory standards.

This office/remote role requires on-site presence, with in-person work 3 days per week.

Qualifications

• Bachelor’s or Master’s degree in a relevant field.
• 3+ years of experience in Medical Device, Quality Assurance/Control, Clinial Research or equivalent.
• Experience with Post Market Complaint Handling and Vigilance Reporting preferred.
• Ability to meet physical, cognitive and environmental requirements for an Office/Remote position.

Responsabilités

• Investigates and resolves highly complex complaints; documents issues and ensures timely solutions.
• Enforces coding standards and updates systems as new codes become available.
• Heads end-to-end investigations; condenses findings and presents a concise overview.
• Leads customer responses and escalates complex matters as needed.
• Trains and mentors new complaint investigations staff on processes and regulatory standards.

Connaissances

Vigilance investigations

Regulatory compliance

Data analysis

Training & mentoring

Formation

Bachelor’s or Master’s degree in Medical Sciences, Healthcare Management, Industrial Engineering, or Supply Chain Management

Description du poste

Job Title

Vigilance Reporting Specialist

Job Description

In this role you

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.

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.

How we work together

We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.

This is an office role.

About Philips

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. Do the work of your life to help improve the lives of others.

• Learn more about our business.
• Discover our rich and exciting history.
• Learn more about our purpose.
• Learn more about our culture.

Philips Transparency Details

The pay range for this position in Nashville TN is $63,000 to $88,200 Annually.

The pay range for this position in Plymouth MN is $67,000 to $92,600 Annually.

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. Details about our benefits can be found here.

At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case.

Additional Information

US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.

Company relocation benefits will not be provided for this position. For this position, you must reside in or within commuting distance to Nashville TN or Plymouth MN.

This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates.

Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.