Intuitive
Post Market Surveillance Adverse Event Analyst
Intuitive, Peachtree Corners, Georgia, United States
Job Description
Primary Function of Position:
The Regulatory Post Market Surveillance Adverse Event Analyst investigates customer complaints related to injury / adverse event / or death cases and makes reporting conclusions, files regulatory reports, and ensures completeness and consistency of complaint documentation. This role includes live telephone intake and documentation of death and injury events phoned in to Intuitive by company representatives and customers. The AE Analyst is responsible for the actions or review of the complaint from intake through closure.
Roles & Responsibilities:
Investigating serious injury / adverse event and death complaints daily
Perform the preliminary classification of complaints including reportability triage and decision making
Conduct complaint investigations including following up with surgeons and other health care professionals via phone and email
Answer live, incoming phone calls for Adverse Events from Customer Service, Technical Service, Intuitive Representatives and hospital site contacts (e.g., surgeons, physicians, operating room personnel). Collect in-depth information as available, and document complaint into the CRM system
Perform reportability determinations in conjunction with medical safety officer, as necessary
Provide input to clinical conclusion to be included in the complaint file and regulatory reports
Escalate complaints that require additional review to engineering, medical safety officer, clinical development engineering, etc.
Accurately select Risk (Hazard, Harms, Severity, matching Clinical Risk Assessment line item) and IMDRF codes
Review product analysis investigation and determine cause / contribution of event to device
Draft and file medical device and vigilance Reports
Evaluate documentation for completeness and consistency
Approve final complaint file for closure after all applicable actions are completed
Manage complaint workload to required timeliness and goals
Collaborate with internal teams including clinical development engineering, human factors, medical safety office, risk management, engineering, and other departments as needed to provide relevant and critical clinical information related to adverse events
Adherence to standard operating procedures and guidance documents across the organization for reporting, investigation and compliance related to post market requirements
Analyze complaint data to identify trends, issues, or systemic discrepancies
Recognize and escalate trends and alert limits or process triggers of safety concerns to defined escalation path to communicate these concerns
Provide the risk management team required data to support and incorporate new failure modes into risk management files
Collaborate with the Medical Safety Office to support monitoring activities and ensure timely escalations.
Collaborate with the Intuitive Legal Department for legal claims
Ensure compliance to post market surveillance processes for regulatory database searches, literature reviews, surveys, and other proactive surveillance
Assess product relationship to reported complaints to root cause
Align to standard regulatory reporting assessment criteria
Collaborate on responses for Regulatory Agency Requests for additional information as assigned
Represent Post Market Surveillance at selected cross functional meetings
Provide monthly, daily, weekly reporting of key metrics and action plans
Drive the progress of complaints throughout the complaint lifecycle to ensure proper documentation and timely closure of each complaint
Participate in internal and external audits
Develop and maintain product knowledge of existing and new products
Maintain awareness of new or revised regulations and/or guidelines
Provide peer review and feedback of complaints and reports
Participate in new hire training and continuous Regulatory Compliance training as required
Participate in process improvement activities to continuously improve process effectiveness
Execute on projects as required
Perform other duties as directed
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The Regulatory Post Market Surveillance Adverse Event Analyst investigates customer complaints related to injury / adverse event / or death cases and makes reporting conclusions, files regulatory reports, and ensures completeness and consistency of complaint documentation. This role includes live telephone intake and documentation of death and injury events phoned in to Intuitive by company representatives and customers. The AE Analyst is responsible for the actions or review of the complaint from intake through closure.
Roles & Responsibilities:
Investigating serious injury / adverse event and death complaints daily
Perform the preliminary classification of complaints including reportability triage and decision making
Conduct complaint investigations including following up with surgeons and other health care professionals via phone and email
Answer live, incoming phone calls for Adverse Events from Customer Service, Technical Service, Intuitive Representatives and hospital site contacts (e.g., surgeons, physicians, operating room personnel). Collect in-depth information as available, and document complaint into the CRM system
Perform reportability determinations in conjunction with medical safety officer, as necessary
Provide input to clinical conclusion to be included in the complaint file and regulatory reports
Escalate complaints that require additional review to engineering, medical safety officer, clinical development engineering, etc.
Accurately select Risk (Hazard, Harms, Severity, matching Clinical Risk Assessment line item) and IMDRF codes
Review product analysis investigation and determine cause / contribution of event to device
Draft and file medical device and vigilance Reports
Evaluate documentation for completeness and consistency
Approve final complaint file for closure after all applicable actions are completed
Manage complaint workload to required timeliness and goals
Collaborate with internal teams including clinical development engineering, human factors, medical safety office, risk management, engineering, and other departments as needed to provide relevant and critical clinical information related to adverse events
Adherence to standard operating procedures and guidance documents across the organization for reporting, investigation and compliance related to post market requirements
Analyze complaint data to identify trends, issues, or systemic discrepancies
Recognize and escalate trends and alert limits or process triggers of safety concerns to defined escalation path to communicate these concerns
Provide the risk management team required data to support and incorporate new failure modes into risk management files
Collaborate with the Medical Safety Office to support monitoring activities and ensure timely escalations.
Collaborate with the Intuitive Legal Department for legal claims
Ensure compliance to post market surveillance processes for regulatory database searches, literature reviews, surveys, and other proactive surveillance
Assess product relationship to reported complaints to root cause
Align to standard regulatory reporting assessment criteria
Collaborate on responses for Regulatory Agency Requests for additional information as assigned
Represent Post Market Surveillance at selected cross functional meetings
Provide monthly, daily, weekly reporting of key metrics and action plans
Drive the progress of complaints throughout the complaint lifecycle to ensure proper documentation and timely closure of each complaint
Participate in internal and external audits
Develop and maintain product knowledge of existing and new products
Maintain awareness of new or revised regulations and/or guidelines
Provide peer review and feedback of complaints and reports
Participate in new hire training and continuous Regulatory Compliance training as required
Participate in process improvement activities to continuously improve process effectiveness
Execute on projects as required
Perform other duties as directed
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