PMS Complaint Handling Specialist

Job Description

Job Title : PMS Complaint Handling Specialist

Job Responsibilities:
u2022 Works under general supervision and established processes and operational policies with independent judgement, investigates and assists in resolving highly complex complaints by monitoring product analysis findings or service analysis notes and ensures the implementation of solutions to address customer concerns efficiently.
u2022 Leads the implementation of good faith efforts (GFE), diligently reviews, and analyzes supplementary data as required to fortify the investigation process and demonstrates a commitment to thoroughness and accuracy.
u2022 Ensures the application of internal follow-up measures to procure further essential information necessary for reinforcing the investigation process, ensuring thoroughness and accuracy in analysis and decision-making.
u2022 Establishes 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.
u2022 Leads 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.
u2022 Reviews customer response letters (CRL) or internal responses upon concluding the investigation, utilizes effective communication and problem-solving skills, and escalates complex matters to appropriate channels for further assistance and resolution.
u2022 Utilizes analytical skills to resolve medium complexity requests by exercising judgment within established procedures, analyzing complaint data, gathering additional information to assess potential product enhancements, defects, and safety issues.
u2022 Handles moderate to high complexity investigations into post-market complaints and adverse events, ensures thorough and timely resolution by analyzing complaint data and documentation to identify trends, root causes, and potential product issues.
u2022 Develops detailed investigation plans with clear objectives, methodologies, and timelines, conducts root cause analyses to identify underlying issues and documents findings, corrective actions, and preventive measures in comprehensive reports.
u2022 Supports 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.

Minimum required Education:
Bachelor's Degree in Medical Sciences, Healthcare Management, Engineering

Minimum required Experience:
Minimum 6-7 years of experience in Medical Device, Quality Assurance, Quality Control, Clinical Research or equivalent
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Preferred Skills:
u2022 Post-Market Surveillance Mechanisms - mandatory

u2022 Vigilance Reporting
u2022 Quality Management Systems (QMS)
u2022 Quality Specifications
u2022 Data Analysis & Interpretation
u2022 Regulatory Requirements
u2022 Technical Documentation
u2022 Root Cause Analysis (RCA)
u2022 CAPA Methodologies
u2022 Complaint Management
u2022 Recordkeeping
u2022 Training Delivery
u2022 Business Acumen

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 companyu2019s facilities.
Field roles are most effectively done outside of the companyu2019s main facilities, generally at the customersu2019 or suppliersu2019 locations.
Indicate if this role is an office/field/onsite 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 the lives of others.
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If youu2019re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our culture of impact with care .