Complaint Handling & Vigilance Reporting Specialist

Job Description

Job title:
Complaint Handling & Vigilance Reporting Specialist

Your role:

• 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.

• 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 customeru2019s 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.

You're the right fit if: (4 x bullets max)
1. Experience- 4+years of experience in Complaints Handling
2. Skills- Complaints Handling, Vigilance reporting, Trackwise
3. Education- Any Engineering
4. Anything else.

• u2022 Post-Market Surveillance Mechanisms
  u2022 Quality Management Systems (QMS)
  u2022 Quality Specifications
  u2022 Data Analysis & Interpretation
  u2022 Regulatory Requirements
  u2022 Technical Documentation
  u2022 Complaint Management
  u2022 Recordkeeping
  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 .