Post Market Surveillance Adverse Event Analyst

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

Qualifications

Skills, Experience, Education, & Training:

• Minimum Undergraduate degree, preferably in life science (e.g., RN, engineering), or undergraduate degree with post-market surveillance experience.
• Operating Room, Surgical, Critical Care experience preferred.
• Minimum 3+ years of experience in medical device field, with experience in the following areas:
• Working knowledge and understanding of the FDA 21 CFR part 803 Medical Device Reporting and part 820.198 for Complaint File management
• Global regulatory medical device requirements for EU, MDSAP countries, and other related requirements

Skills - The following skills are required for this position:

• Effectively prioritize / multi-task numerous activities in a rapid paced environment
• Demonstrate exceptional written and verbal communication skills
• Effective computer skills (Excel, Word, PowerPoint, database query)
• Efficient at autonomously working with ability to focus
• Attention to detail
• Demonstrate cross functional communication skills in email and in person
• Demonstrate customer service based phone communication skills / obtain event details live from varied disciplines (hospital personnel, Intuitive representatives) in a professional manner
• Proven analytical and Excellent organizational skills
• Ability to handle and manage workload autonomously
• Contribute to team-oriented tasks
• Excellent interpersonal and decision-making skills

Competency / Training - The following competencies are essential for this position:

• Firm understanding of Regulatory reporting requirements for Medical Devices and complaint system and process requirements including good documentation practices and quality system elements.
• Firm understanding of quality records requirements and how they apply to complaint files.
• Familiarity with world-wide regulatory reporting requirements.
• Able to make decisions quickly using information at hand and evaluate the need to obtain clarification and direction when necessary.