CH and Vigilance Reporting Specialist

Job Title

Job Description

Title: The PMS Complaint Handling Investigator

Is responsible for meticulously reviewing documenting and maintaining complaint records in compliance with regulatory standards conducting investigations and facilitating continuous improvement initiatives and collaborating with stakeholders to ensure comprehensive data gathering and analysis for informed decision-making. The role applies suitable coding to enhance data organization and analysis enabling swift resolution and insights for improving procedures. The role identifies routine mid-complexity issues escalating to higher-level investigators as required. The role compiles and presents records at management review meetings for comprehensive discussion and decision-making.

Job Responsibilities:
Works under direct supervision and established processes and operational policies reviews and documents complaints precisely and accurately ensuring comprehensive capture of relevant information and adherence to regulatory and organizational requirements.
Ensures detailed records of complaints are maintained including investigation findings and resolution actions taken to support post-market surveillance activities and facilitate continuous improvement initiatives aimed at enhancing product quality and customer satisfaction.
Reviews and assesses complaint intake records from various channels for alignment with complaint definitions and regulatory requirements and conducts duplicate checks to eliminate redundant records and ensure data accuracy and integrity in post-market surveillance activities.
Conducts moderate Good Faith Efforts (GFE) when necessary to collect additional data supporting the evaluation and escalation of the record. Collaborates with relevant stakeholders to ensure comprehensive data gathering adhering to regulatory requirements and internal protocols.
Ensures application of suitable coding reviews the input into the complaints process enhances data organization and analysis applies reported problem coding to record the customers experience and enables swift resolution and valuable insights for improving procedures and addressing recurring issues.
Identifies routine mid complexity issues determines if escalation to a Level 2 or Level 3 Investigator is required and escalates complaint records to a complaint operations specialist or manager.
Follows internal follow-up measures to procure further essential information necessary for reinforcing the investigation process ensuring thoroughness and accuracy in analysis and decision-making.
Compiles records for various topics presents them at the daily management review meeting and ensures a comprehensive overview of relevant information for discussion and decision-making.
Prepares comprehensive investigation reports that include findings conclusions and actions taken ensures accuracy and currency in maintaining complaint files and records to facilitate effective communication of investigation outcomes and support continuous improvement efforts.
Develops stable working relationships internally exchanges standard information with colleagues immediate supervisor project leaders and other professionals in the team/group.

Minimum required Education:
Bachelors Degree in Sciences Healthcare Management Industrial Engineering Supply Chain Management or equivalent.

Minimum required Experience:
Minimum 3 years of experience in Medical Device Quality Assurance Quality Control Clinical Research or equivalent with Vocational Education.

Preferred Skills:
Post-Market Surveillance Mechanisms
Quality Management Systems (QMS)
Risk Management
Data Analysis & Interpretation
Regulatory Requirements
Technical Documentation
Complaint Management
Recordkeeping
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 companys facilities.
Field roles are most effectively done outside of the companys main facilities generally at the customers or suppliers 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 wont 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 youre 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 here.