1. TRACY CADET
72 Centennial Ave
Cranford, NJ 07016
(908) 494-0511
Tracycadet@gmail.com
Summary
A polished professional seeking an opportunity that will allow me to utilize my strong organizational and
multi-tasking skills while adding value within any team environment.
Ability to work without close supervision.
High attention to detail and accuracy.
Advanced written and oral communications skills.
Able to manage multiple tasks.
Ability to work under pressure and meet timelines.
Ability to understand SOPs and related process documents
Solid knowledge of medical terminology gained through prior coursework and experience.
Solid knowledge of FDA, ICH and GCP regulations gained through prior coursework and experience.
Solid knowledge of clinicaltrials.gov website gained through prior coursework.
Solid knowledge and understanding of Clinical Study Reports (CSR) gained through prior coursework.
Solid knowledge of CSRs and CERs gained through prior coursework and experience.
Education:
Clinical Data Management Certification
Raritan Valley Community College, North Branch, NJ
Certification of Management of CRF Title 21 Part 11 Compliance
CRA/CRC Certification
Raritan Valley Community College, North Branch, NJ
Drug Supply and Accountability Certification
Raritan Valley Community College, North Branch, NJ
Computer Skills:
Microsoft Office Suite
Lotus Notes
ArisG
Argus
Remetrex CHATS
Siebel
COGNOS
MiniTab
Adobe Acrobat
Documentum
Employment:
GE Healthcare
Princeton, NJ
Pharmacovigilance Specialist I 12/2014 – Present (Contract Remote)
• Support Clinical and Post-Marketing Safety Experts in processing adverse event reports from all
sources including clinical trials, post-marketing and published literature
• Full Data Entry of Serious/Nonserious Cases
• Narrative Writing

2. TRACY CADET
• Quality control
• Follow-up handling as triggered by ARISg Serious/Nonserious data entry and data entry
MedDevice case data entry and data entry.
• Labeling and Distribution
• Responsible for coordinating and handling all incoming and outgoing reporting if Individual Case
Safety Reports (ICSR) in compliance with applicable pharmacovigilance requirements and
standards.
• Perform coding of adverse events and WHO drugs with the help of MedDRA
• Maintaining a daily overview of the workflow to ensure all reports are completed within regulatory
timeframe, distributing required ICSRs to subsidiaries and distributors via email and EVWEB.
• QC and review patient’s cases ensuring all information are entered correctly and efficiently.
• Registration and data entry of ICCSRs, including lack of efficacy cases into reporting database
such as ARISg and into EVWEB where applicable. Conducting batch number inquiries in ARISg
to identify ICSR associated with batches for quality Assurance purposes.
• Keeping safety logs, i.e., to require feedback about reporting of ICSRs to national competent
authorities on a regular basis in order to monitor regulatory compliance.
• Perform Submission and Distribution to Partners and Authorities. Such as E2B, EMEA, FDA,
PSUR, and IND, and NDA. In addition generate CIOMS /MedWatch, Query for
submission/distribution in accordance with safety data exchange agreements.
Ethicon
Somerville, NJ
World Complaint Quality Engineering Analyst 07/2014 – 12/2014 (Contract)
• Perform follow-ups to cases
• Initial and follow-up electronic data entry in Siebel
• Review Trend Analysis.
• Case review prior to closure
• Complete Special Assignments
• Collaborates with cross functional groups to drive process improvements and regulatory compliance.
• Perform Data Validation and Clean up in Siebel.
• Mentor and onboard new Analyst.
Somerville, NJ
Post Marketing Surveillance Engineering Analyst 01/2013 – 06/2014 (Contract)
• Performs post-market safety and surveillance activities including trend analyses, investigations
and metric generation.
• Executes the PMS process with a primary focus on product performance, safety and efficacy.
• Interface with internal partners, mainly, R&D, Operations, Medical Affairs and Marketing to drive
the consistent input and analysis of PMS data.
• Data analytics
• Interfaces with electronic systems (e.g. Remetrex CHATS, ADAPTIVE, SIEBEL, COGNOS)
• Determines negative trend while identifying corrective/preventive action team.
• Perform data quality checks & reviews

3. TRACY CADET
• Works independently with minimal supervision. Supports safety and environmental initiatives.
• Mentor and onboard new contractors.
Novo Nordisk
Princeton, NJ
Project Associate 06/2012 – 10/2012(Contract)
• Assist in providing accurate, fair balanced, and current medical and technical information about
company's products to healthcare professionals, key institutions, managed care organizations and
the broader medical and academic community
• Medical Accuracy review of materials
• Assist MA members in preparing for major presentations as requested.
• Assist in preparation and implementation of MA KOL engagement plans and strategy
• Assist in preparation and implementation of patient/association advocacy plan.
• Assist in creation, development, and presentation to IME internal stakeholder
• Assist in maintenance of publication tracking tool
• Complete projects as assigned from Director, Medical Affairs or Manager, Medical Affairs
• Proofread Articles
• Monitor Approval processes for Articles
Pfizer
New York, NY
Safety Data Assistant 07/2011 – 06/2012 (contract)
• Monitor and manage dedicated DSU mailboxes
• Maintain local documentation as required by legislation (including archiving/tracking/retrieval)
• Support the submission and distribution of reports and relevant tracking
• Support distribution and tracking of distribution of Follow-Up letters
• Support inspection preparedness activities
• Consistently apply Book-in & Data Entry policies and practices as per Company SOPs
• Consistently apply Book-in & Data Entry of Adverse Events.
• Consistently apply Archiving policies as per Company SOP
• Coordinate and Distribute: SUSARs, SUSAR Line Listings, SUSARs to IIR investigators and Biannual
IIR Line Listings within the U.S.(Includes running the PR/PI reports and manipulating the DL)
• Consistently perform quality checks to ensure accuracy.
• Assemble the SUSAR components and distribute within 3 calendar days and no later than day 14, (Day
0 is "Pfizer awareness date")
• Create UPS shipping labels using the UPS WorldShip application
• Send various e-mails (TMF, Undeliverable, UPS Invoice Correction, successful Delivery Notification)
• Follow-up on all non-deliverables, maintaining a tracking spreadsheet and re-distribute according to
current process
• Reply to phone inquires or forward to appropriate party
• Complete Daily Report and forward to SUSAR management
Bayer Healthcare Pharmaceuticals
Montville, NJ
Safety Data Associate 01/2011 – 7/2011 (contract)

4. TRACY CADET
• Using multiple iterations of key data perform searches in the Argus affiliate database to identify
potential duplicate information.
• Initial and follow-up electronic data entry of legal cases.
• Book-in of cases (spontaneous, clinical trial, and/or literature) in Argus
• Analyze the search results to determine if the information is follow-up or additional information to a
pre-existing case, or if a new case needs to be created per departmental guidelines.
• Perform daily analysis between the adverse event reports received from patient support programs to
the drug safety database to reconcile that all adverse events have been received and entered for
submission to the Regulatory Authorities per departmental guidelines.
• Write and send queries to the patient program managers to clarify missing or incorrect information to
ensure that all adverse event information is accurately reported.
• Perform weekly analysis between the adverse events received from Medical Communications and
the drug safety database to reconcile that all adverse events have been received and entered for
submission to Regulatory Authorities.
• Write and send queries to Medical Communications staff to clarify missing or incorrect information
per departmental guidelines.
• Prioritize and accurately perform minimal data entry for both serious and non-serious adverse event
reports into the Argus affiliate database per departmental guidelines.
• Scan and attach all source documents to the correct case in the drug safety database ensuring all
pages have been accounted for to protect source document integrity and to ensure that documents
are available for assessment globally.
• In conjunction with the Safety Information Assistant, create the case files and route the case to the
next workflow state
Novartis Consumer Health
Parsippany, NJ
Drug Safety Associate 01/09 – 09/09 (Contract)
• Perform duplicate searches in the Consumer Relationship Tracking System (CRTS) and Argus
databases
• Book-in of cases (spontaneous, clinical trial, and/or literature) in Argus
• Full Data Entry of Serious and Non-serious cases, including:
Adverse Events, labs, and patient history from source documents
• Product coding
• MedDRA coding in accordance with guidelines and conventions
• Narrative Writing
• Submit Cases to FDA
• Perform follow-ups to cases
• Pull Cases from Documentum
• Generate and track requests for follow-up
• Inform Case Processing and Quality, Training & Compliance groups of late cases
• Ongoing mentorship/training to entry level Drug Safety Associates (DSAs)
• Provide basic metrics to management on an as needed basis
• Provide back-up coverage for when needed
• Perfomed E2b Testing and validation through Argus
Forest Laboratories
Jersey City, NJ
Drug Safety Assistant 11/08 – 12/08 (Contract)
• Received incoming safety information
• Enter data in ARISg5

5. TRACY CADET
• Assembled and qualified the information for completeness
• Confirmed receipt with Associated Business Partners when applicable, and prepared for triage
• Conducted follow-up with the reporter when one of the four essential criteria is missing and screens
for duplicate information
Johnson & Johnson
Morris Plains, NJ
Safety Analyst 08/07 – 08/08 (Contract)
• Perform ad-hoc and standard searches in ARISg create related documentation
• Log and track incoming requests
• Perform system administration tasks
• Perform data quality checks & reviews
• Trouble shoot errors with Local Case Reporting and E2B
• Other Tasks as Assigned
• Perform User Acceptance Testing
• Develop and maintain procedures and guidelines
• Perform Surveillance Reports
• Mentor and train new employees
• Initiated new policies and procedures
• Perform medical coding using MedDRA and WHO-Drug dictionaries
• Created, managed and reviewed SOPs
Schering-Plough Corporation
Berkley Heights, NJ
Data Coordinator 03/07 – 07/07 (Contract)
• Data entry
• Data query resolution
• Filing
• Tracking and assurance of data quality
• Records Retention and Retrieval

6. TRACY CADET
• Assembled and qualified the information for completeness
• Confirmed receipt with Associated Business Partners when applicable, and prepared for triage
• Conducted follow-up with the reporter when one of the four essential criteria is missing and screens
for duplicate information
Johnson & Johnson
Morris Plains, NJ
Safety Analyst 08/07 – 08/08 (Contract)
• Perform ad-hoc and standard searches in ARISg create related documentation
• Log and track incoming requests
• Perform system administration tasks
• Perform data quality checks & reviews
• Trouble shoot errors with Local Case Reporting and E2B
• Other Tasks as Assigned
• Perform User Acceptance Testing
• Develop and maintain procedures and guidelines
• Perform Surveillance Reports
• Mentor and train new employees
• Initiated new policies and procedures
• Perform medical coding using MedDRA and WHO-Drug dictionaries
• Created, managed and reviewed SOPs
Schering-Plough Corporation
Berkley Heights, NJ
Data Coordinator 03/07 – 07/07 (Contract)
• Data entry
• Data query resolution
• Filing
• Tracking and assurance of data quality
• Records Retention and Retrieval