Job Description

Job Title Vigilance Reporting Specialist Job title: Vigilance Reporting Specialist Your role: Ensures timely global medical device reporting by assessing complaints against reporting requirements and facilitating any required further investigation. Writes and submits medical device reports (MDRs) and /or regulatory reporting Working with a variety of diverse persons within the company such as Complaint Investigators, PMS Clinical Experts, CH Market Experts, Engineers, Scientists, Field Service & Application Engineers and Manufacturing personnel to facilitate reportable device events in accordance with written procedures and global reporting requirements. Utilizing global decision trees and country specific exemptions to determine worldwide complaint reporting requirements and serious public health threat applicability in accordance with written procedures and global reporting requirements Collaborating with Level 3 complaint investigator to determine the need for Clinical Assessment and Clinical Harm Review. Providing review of complaint to ensure all information needed for Reporting/MDRs is present determine if further investigation is needed and track investigation to conclusion. Writing MDRs/MIR reports and submits to the necessary authorities Monitoring and improving tracking/control systems for medical device reporting Responding to and collaborating with complaint investigators and PMS Clinical Experts to ensure complaint investigation results and clinical subject matter expertise is considered and documented related to regulatory reporting decision making, assessment of event severity and causality, and rationale for escalation of complaints. Concisely documenting rationale to support reportability decision making related to potential reportable malfunctions and aligns with PMS Clinical Expert on documented rationale related to complaints describing death and injury. Communicating with Product Safety risk managers to disposition complaints that potentially reflect new harm, harm higher severity than predicted in the risk management documentation and/or escalation to IIA/CAPA The coordination and collaboration with PMS Clinical Experts, Complaint investigators and business representatives to prepare responses to regulators and competent authority inquiries when needed. Providing consultation with risk management and product engineering teams when necessary to understand the impact of device failures on device performance to determine the potential for patient injury/harm Working with a variety of diverse persons within the company such as Complaint Investigators, PMS Clinical Experts, CH Market Experts, Engineers, Scientists, Field Service & Application Engineers and Manufacturing personnel to facilitate reportable device events in accordance with written procedures and global reporting requirements. Utilizing global decision trees and country specific exemptions to determine worldwide complaint reporting requirements and serious public health threat applicability in accordance with written procedures and global reporting requirements Collaborating with Level 3 complaint investigator to determine the need for Clinical Assessment and Clinical Harm Review. Providing review of complaint to ensure all information needed for Reporting/MDRs is present determine if further investigation is needed and track investigation to conclusion. Writing MDRs/MIR reports and submits to the necessary authorities Monitoring and improving tracking/control systems for medical device reporting Responding to and collaborating with complaint investigators and PMS Clinical Experts to ensure complaint investigation results and clinical subject matter expertise is considered and documented related to regulatory reporting decision making, assessment of event severity and causality, and rationale for escalation of complaints. Concisely documenting rationale to support reportability decision making related to potential reportable malfunctions and aligns with PMS Clinical Expert on documented rationale related to complaints describing death and injury. Communicating with Product Safety risk managers to disposition complaints that potentially reflect new harm, harm higher severity than predicted in the risk management documentation and/or escalation to IIA/CAPA The coordination and collaboration with PMS Clinical Experts, Complaint investigators and business representatives to prepare responses to regulators and competent authority inquiries when needed. Providing consultation with risk management and product engineering teams when necessary to understand the impact of device failures on device performance to determine the potential for patient injury/harm You\'re the right fit if: (4 x bullets max) 1. Experience- 4-6yrs of experience in Complaints Handling and Vigilance Reporting 2. Skills.- Trackwise experience in must, Good internpersonal skill. 3. Education- Bachelor Degree in Engineering 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. . Learn more about . . Discover . . Learn more about . If you\'re 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 commitment to diversity and inclusion .

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