Carol Wilson
Mahaffey,PA
Summary
My expertise of performing Medical Record Review is unique. I've worked many years for major pharmaceutics and device companies as a consultant, where I have reviewed numerous medical records for litigation as well as performing literature search and review for compliance purposes. Litigation and compliance medical review has provided me with a unique skill of analytical thinking, which is a key factor in the review of complex medical records, clinical trial audits and safety reporting of drugs and product malfunctions.
Overview
29
29
years of professional experience
1
1
Certification
Work History
Clinical Product Safety Specialist
Olympus
01.2023 - 04.2023
- Responsible for completing MedWatch product malfunctions via EtQ
- Utilized MedDRA for Adverse Event coding & FDA product malfunction codes per MedWatch requirements.
Clinical Product Safety Specialist
Inogen
01.2022 - 06.2022
- Responsible for documentation of Oxygen product, tracking calls made to the consumer to determine if the complaint was an adverse event or product malfunction via Salesforce.
EU PSUR Writer
Johnson & Johnson
12.2020 - 04.2021
- Responsible for the Coordination and Collection of critical reports required to write the European Union Medical Device Regulation (EU MDR)
- Such as (Clinical Study Reports, Technical File, Post-Marking Surveillance Report, Risk Analysis Report) for DePuy/Synthesis products (Class II & III)
- Exceeded timelines as well as maintaining accuracy
- Collaborated with Manager on determining the best solution for organizing, searching, sorting, & filing Reliable - step in and perform work of a team member, who was off ill in order to meet timelines.
Clinical Product Safety Specialist
Pfizer
05.2020 - 08.2020
- Peer Clinical Review of Combination Product (Human Growth Hormone) via Track Wise for Device part
- Responsible for review of Decision Tree
- Proactive in training of new team members
- Work environment – fast pace; all assignments were completed within timelines with high quality results.
Clinical Product Safety Specialist
Philips North America
08.2019 - 05.2020
- Responsible for review & coding of Intensive Care Unit & Emergency Medical Team (EMT) device equipment related complaints
- Select appropriate coding for trending and analysis purposes
- Work environment – fast pace at times - Exceeded timelines as well as maintaining accuracy
Product Safety Specialist
Aesculap
01.2019 - 05.2019
- Responsible for device (Class III) post-marketing complaints review and completing MedWatch via SAP.
Clinical Coder
AbbVie Inc.
06.2018 - 12.2018
- Performed Quality Control of adverse events and concomitant medications coded for consistency and accuracy
- Performed weekly coding reports utilizing TMS database.
Product Safety Specialist
Cook Medical
04.2018 - 05.2018
- Responsible for completing MedWatch for product malfunctions
- Utilized MedDRA for Adverse Event coding & FDA product malfunction codes per MedWatch requirements
- Collaborated with Engineers on product investigations.
Clinical Product Safety Specialist
INC Research
05.2016 - 11.2017
- Responsible for processing non-serious & serious adverse events complaints for Allergan product and completed MedWatch via Argus
- Utilized WHO & Med DRA for Drug and Adverse Event coding
- Utilized Investigator Brochure (IB), Core Data, and Package Insert (PI) for relatedness of adverse event
- Work environment – fast pace at times - Exceeded timelines as well as maintaining accuracy
Lead Safety Surveillance Specialist
Allergan
06.2015 - 09.2015
- Responsible for reviewing labeling with brochures/advertising for consistency and accuracy for breast implants
- Responsible for Quality Control (QC) of clinical trial data.
Product Safety Specialist
ConvacTec
11.2014 - 06.2015
- Responsible for processing non-serious adverse events complaints and completed MedWatch forms
- Utilized MedDRA for Adverse Event coding
- Responsible for rational based on reported severity
- Ensured Root-Cause analysis forwarded to Subject Matter Expert (SME)
- Utilized Investigators Brochure (IB), Core Data, and Package Insert (PI) for assessment relatedness of the adverse event
- Proactive in training for new team members
- Work environment – fast pace at times - Exceeded timelines as well as maintaining accuracy
Clinical Medical Data Reviewer
UCB Pharmaceuticals
11.2010 - 09.2014
- Performed medical data review for numerous clinical trials from the time of enrollment to database lock
- Generated queries for missing information or to provide clarification
- Collaborated with the Data Management Team in the development of Data Cleaning Plan
- Exceeded timelines as well as maintaining accuracy.
Medical Device Data Reviewer
Fresenius
02.2014 - 05.2014
- Reviewed complaints for Dialysis devices for Adverse Events and product malfunctions
- Confirmed patient/Sales person contact information
Clinical Device Compliance
DePuy Synthes/Anspach, J & J
06.2013 - 02.2014
- Performed Peer Review of complaints for Anspach (power tools) & DePuy/Synthes products (Class III implantable devices)
- Evaluated X-Rays and other imagining of surgeries for determining complaint Reportability
- Proactive in training new team members on the device complaint process & completing the MedWatch form as well as performing Literature reviews
- Lead for utilizing the Global Rational Tool program for providing rationale’s for all Anspach products
- Collaborated effectively with Engineer team regarding device investigations
- Work environment – fast pace at times - Exceeded timelines as well as maintaining accuracy
Clinical Trial QC/Auditor
Falcon Consulting Group
04.2012 - 09.2012
- Performed Clinical Trial Audits & Quality Control (QC) that included Trial Master Files and Investigators Site Files for numerous sponsors and Clinical Research Origination’s (CRO’s) in accordance with Falcon and the clients Standard Operational Procedures (SOPs) and Good Clinical Practices (GCPs).
Clinical Medical Data Reviewer
Parexel
03.2010 - 09.2010
- Performed medical & clinical data review for numerous clinical trials for accuracy & completeness of data
- Responsible for querying missing information &/or provide clarification
- Exceeded timelines as well as maintaining accuracy.
Clinical Drug Safety Specialist
Celgene Pharmaceutical
09.2009 - 10.2009
- Responsible for the processing of non-serious adverse events completed MedWatch form
- Utilized WHO & MedDRA for Drug and Adverse Event coding
- Utilized Investigators Brochure (IB), Core Data, and Package Insert (PI) for relatedness of adverse event.
QC & Medical Writer
Falcon Consulting Group
04.2007 - 02.2009
- Created departmental Standard Operational Procedures (SOP’s), policies, and guidelines
- Performed Quality Control (QC) of Investigators Site study files against the Trial Master file
- Independently created comprehensive narratives for each adverse event report and performed document QC a total of 160 safety narratives for all adverse events that were related to respiratory and dermatology
- Inventory of numerous FDA correspondence Oxycodone files, scanned documents into electronic data base.
Clinical Drug Safety Specialist
Therakos
09.2005 - 09.2006
- Created Quarterly Trending and Analysis Reports for Extracorporeal photopheresis (ECP) in treatment for graft-versus-host disease (GVHD), including lab data, serious and non-serious events
- Completed medical review of clinical trial complaint & completed MedWatch form
- Performed Quality Control (QC) of numerous clinical trials for Rheumatoid Arthritis and Cutaneous T-cell Lymphoma
- Created and updated various safety Standard Operating Procedures (SOP's)
- Performed edits and Quality Control (QC) for various Regulatory document
- Created Pregnancy Adverse Event forms along with a Step-by-Step Guide for completing forms
- Created Training Guide for Drug Safety Specialist duties
- Created Power Point presentations for a variety of in-house and clinical trial sites training.
Drug Safety Specialist
Bristol Myers Squibb
03.2005 - 09.2005
- Reviewed medical records for estrogen litigation cases
- Responsible for the processing of serious and non-serious adverse events for spontaneous, solicited, clinical trials, and litigation complaints & completed MedWatch form
- Utilized WHO & MedDRA for Drug and Adverse Event coding
- Utilized Investigators Brouchure (IB), Core Data, and Package Insert (PI) for relatedness of adverse event.
Clinical Drug Safety Specialist
Merck Pharmaceuticals
11.2004 - 03.2005
- Reviewed Medical Record for Vioxx litigation cases
- Created comprehensive narratives.
Clinical Drug Safety Specialist
Pfizer
06.2003 - 11.2004
- Responsible for processing non-serious adverse events complaints for Lipitor (post-marketing, spontaneous, solicited, and clinical trials) and completed MedWatch forms
- Utilized WHO & MedDRA for Drug and Adverse Event coding
- Utilized Investigators Brochure (IB), Core Data, and Package Insert (PI) for relatedness of adverse event
- Exceeded timelines as well as maintaining accuracy.
Nurse Supervisor
Philipsburg Area Hospital
12.2002 - 06.2003
- Responsible for all administrative decisions during evening and weekend shifts
- Managed staffing of the emergency department, intensive care unit, and medical surgical units
- Acted as a liaison between patients, staff, and physicians.
Clinical Safety Supervisor
Arthrex, Inc.
09.2001 - 10.2002
- Supervised call center for serious adverse events & reportability.
- Generated Quarterly Trending and Corrective Action Protective Action (CAPA) Analysis Report
- Led the restructuring of Safety/Complaints Department
- Collaborated with Information Technology (IT) in the development and design for a database used to capture patient related events vs
- Product malfunction
- Manage the coordination of reporting activities for Serious Adverse Event (SAE) from open to close
- Collaborated with engineering team as well as internal team to ensure all complaint issues are addressed prior to closing a complaint
- Assisted with writing 510K submissions along with other Regulatory responsibilities
- Generated Standard Operating Procedures (SOP), implementation, and training of staff
- Generated an Investigational Device Exemption (IDE) based on a foreign country clinical study.
Certified Clinical Research Coordinator
Anchor Research
05.1999 - 09.2001
- Managed up to 8 clinical trials, ranging from phase II-IV in a wide variety of therapeutic areas
- Managed regulatory documents, screening and signing of informed consent (IC), completing Case Report Forms (CFRs), and reporting serious adverse events to the Institutional Review Board (IRB) and Sponsor within the mandatory time line.
Clinical Research Coordinator
ClinSites/Lee Coast Research, Inc
10.1998 - 05.1999
- Managed up to 10 clinical trials, ranging from phase I-IV in a wide variety of therapeutic areas
- Supervised staff for the overnight and weekend Phase I clinical trials
- Managing regulatory documents, screening and signing of informed consent (IC), completing Case Report Forms (CFRs), and reporting serious adverse events to the Institutional Review Board (IRB) and Sponsor within the mandatory time line.
Registered Nurse
Naples Community Hospital
10.1996 - 10.1998
- Specialized in Neurology
- Performed in-hospital RN responsibilities.
Registered Nurse
Cross Country Healthcare
05.1995 - 10.1996
- Specialized in Orthopedic
- Performed in-hospital RN responsibilities.
Registered Nurse
Stuart Circle Hospital
05.1994 - 05.1995
- Specialized in Neurology and Orthopedic
- Performed in-hospital RN responsibilities.
Education
Associate Degree of Nursing - Nursing
J. Sargeant Reynolds Community College
Richmond, Virginia01.1994
Bachelor of Science Degree - Health And Physical Education
Virginia Commonwealth University
Richmond, Virginia01.1992
Skills
Clinical Trial Quality Control (QC)/Auditor, Clinical Drug Safety Specialist, Clinical Product Safety Specialist, Clinical Medical & Device Data Reviewer, Clinical Coder, EU PSUR Writer, & Medical Writer
Certification
- Pennsylvania State Registered Nurse License, RN 542328, Apr2024
- Certified Clinical Research Coordinator, Association of Clinical Research Professionals (ACRP), April 2000
Training
- American Medical Writer Association (AMWA): Medical writing, educational/teaching brochures, and advertising literature Food and Drug Administration (FDA)
- Clinical Monitoring Practices
- Clinical Study Reports (CSRs)
- Current Good Manufacture Practices (CGMP) 21 CFR Parts 808, 812, & 820
- Good Clinical Practices (GCP) 21 CFR Parts 11, 50, 54, & 56 (etc.)
- International Council for Harmonization (ICH)
- Medical Device Complaints Reporting
- Quality Systems (QS)
Timeline
Clinical Product Safety Specialist
Olympus
01.2023 - 04.2023
Clinical Product Safety Specialist
Inogen
01.2022 - 06.2022
EU PSUR Writer
Johnson & Johnson
12.2020 - 04.2021
Clinical Product Safety Specialist
Pfizer
05.2020 - 08.2020
Clinical Product Safety Specialist
Philips North America
08.2019 - 05.2020
Product Safety Specialist
Aesculap
01.2019 - 05.2019
Clinical Coder
AbbVie Inc.
06.2018 - 12.2018
Product Safety Specialist
Cook Medical
04.2018 - 05.2018
Clinical Product Safety Specialist
INC Research
05.2016 - 11.2017
Lead Safety Surveillance Specialist
Allergan
06.2015 - 09.2015
Product Safety Specialist
ConvacTec
11.2014 - 06.2015
Medical Device Data Reviewer
Fresenius
02.2014 - 05.2014
Clinical Device Compliance
DePuy Synthes/Anspach, J & J
06.2013 - 02.2014
Clinical Trial QC/Auditor
Falcon Consulting Group
04.2012 - 09.2012
Clinical Medical Data Reviewer
UCB Pharmaceuticals
11.2010 - 09.2014
Clinical Medical Data Reviewer
Parexel
03.2010 - 09.2010
Clinical Drug Safety Specialist
Celgene Pharmaceutical
09.2009 - 10.2009
QC & Medical Writer
Falcon Consulting Group
04.2007 - 02.2009
Clinical Drug Safety Specialist
Therakos
09.2005 - 09.2006
Drug Safety Specialist
Bristol Myers Squibb
03.2005 - 09.2005
Clinical Drug Safety Specialist
Merck Pharmaceuticals
11.2004 - 03.2005
Clinical Drug Safety Specialist
Pfizer
06.2003 - 11.2004
Nurse Supervisor
Philipsburg Area Hospital
12.2002 - 06.2003
Clinical Safety Supervisor
Arthrex, Inc.
09.2001 - 10.2002
Certified Clinical Research Coordinator
Anchor Research
05.1999 - 09.2001
Clinical Research Coordinator
ClinSites/Lee Coast Research, Inc
10.1998 - 05.1999
Registered Nurse
Naples Community Hospital
10.1996 - 10.1998
Registered Nurse
Cross Country Healthcare
05.1995 - 10.1996
Registered Nurse
Stuart Circle Hospital
05.1994 - 05.1995
Associate Degree of Nursing - Nursing
J. Sargeant Reynolds Community College
Bachelor of Science Degree - Health And Physical Education
Virginia Commonwealth University
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