Principal Lead, Clinical Product Surveillance
Resume:
Susan Ly
Telephone: 626-***-**** Email: *****.***.**@*****.***
Address: ***** *. ***** ****., ******, TX, 78753
WORK EXPERIENCE
Principal Lead, Clinical Product Surveillance, Allergan Medical, Austin, TX
(June 2014-April 2015)
Investigated and conducted follow-ups for reported adverse events and device complaints for Class III post-market surveillance medical devices.
Trained and provided continual guidance to approx. 10-15 new hires per quarter on complaint processing procedures and FDA event problem codes.
Reviewed MedWatch Form FDA 3500A, Alternative Summary Reports, Post-Market Approval Reports and any additional reports submitted to the FDA.
Audited approx. 1500 complaint records quarterly to ensure 100% quality, compliance and adherence to complaint handling procedures.
Reviewed internal training documents to ensure procedures are consistent with federal regulations.
Collaborated with Regulatory, Quality Assurance, Customer Support, Device Analysis Lab and other appropriate groups to ensure accurate FDA MDR reports.
Participated in FDA regulatory inspections as required.
Senior Clinical Product Surveillance Analyst, Allergan Medical, Santa Barbara, CA
(January 2012-June 2014)
Investigated and evaluated Class III post-market surveillance medical device complaints.
Determined escalation and categorized severity of adverse events.
Reviewed medical documents and term-coded complaints in accordance with FDA codes.
Knowledge of FDA regulations (21 CFR 803 and 820) and ISO standards (13485).
Reviewed and submitted reportable events through appropriate reporting methods to competent authorities: MedWatch 3500A/eMDR, Adverse Drug Events (ADE), Vigilance, Alternative Summary Reports (ASR), Post-Market Approval Reports (PSR) and other foreign regulatory bodies.
Lead development of internal complaint handling operational policies and procedures.
Reviewed and approved closure of complaint records.
Tracked effectiveness of training curriculum and trainees’ progress.
Clinical Product Surveillance Analyst, Allergan Medical, Santa Barbara, CA
(February 2008-June 2011)
Opened and initiated complaint records.
Investigated the causality and device relationship of reported complaints.
Documented all external correspondences upon receipt from physicians, nurses, patients.
Determined if the event would be reported to the FDA.
Gathered device history records, sterility lot numbers, autoclave confirmations, relevant manufacturing information.
Consulted with internal medical specialists on escalated and severe adverse events to assess the risk to the patient and the public.
Coordinated with our CROs and CRAs to ensure completions of case report forms.
Developed the department’s preliminary training manuals and MDR processes.
Human Resource Associate, Allergan Medical, Santa Barbara, CA
(October 2007-February 2008)
Scheduled temporary staff through employment agencies.
Daily maintenance of HRIS systems: entering new employees, issuing time cards, updating employee information, Benefits Enrollments.
Coordinate with managers to ensure employees are on the correct schedule patterns.
Place and monitor employee ads.
Preliminary screening of job applicants.
Conduct administration portion of new-hire orientation.
EDUCATION
Walden University, Minneapolis, Minnesota
M.S. in Clinical Research Administration (current)
University of California, Santa Barbara, Goleta, California
B.A. in History (2007)
COMPUTER SKILLS
Trackwise
Excel
QueryMonkey
Business Objects
PowerPoint
QUMAS
Microsoft Word
InForm Database
Visio
SAP
Learning Management Systems (LMS)
Outlook and other E-mail applications
Data Analytics
FirstDoc Electronic Doc Management
ACTIVITIES & ACCOMPLISHMENTS
Lean Six Sigma Trained
Repetitive Peer Recognition Award for Outstanding Leadership and Ethics
Recognized for Top Employee of the Year Award 2012 and 2013
Participated in the Santa Barbara Triathlon 2010 & Goleta Triathlon 2012
REFERENCES AVAILABLE UPON REQUEST
Contact this candidate