Corrali T. Joshua-portier ATLANTA, GA ***** PHONE-404-***-****

acfr85@r.postjobfree.com

KEY QUALIFICATIONS

• Experience and expertise with providing administrative support, customer service, quality

control, adverse event reporting, data entry services with various private, and federal government

agencies.

Professional Experience

SciStaff/Novartis (Alcon) 11460 Johns Creek Park Duluth, GA 30097 678-***-****

06/2014 – 09/2014

Adverse Event Product Safety Expert

Accurate & timely reporting, effective investigations, proper analysis, timely filing of Adverse Events and

compliance with international (e.g. FDA, ISO), regional (e.g. MDD) & country (e.g. France, Japan)

regulations; Application of technical knowledge to provide direction and coordinate additional complaint

activities with internal, field, and end use customers; Perform triage of incoming AE reports for

classification, completeness, consistency and seriousness; prioritize and report per regulatory and

company guidelines; Evaluation of incoming field reports, product returns and product analysis results

for products to determine; Adverse event reporting eligibility, complaint status and cause of event;

Initiation and completion of regulatory reports for timely submission to domestic and international

regulatory authorities; Perform Quality Control reviews of cases identifying critical missing information

and communicate recommendations to processors; Building of external partnerships with affiliates,

business partners and others as needed to enhance knowledge of the safety reporting process; identify and

resolve potential compliance issues and optimize data flow in support of signal identification and risk

management; Assist in the development of product quality data, statistical analysis and complaint

trending for Global Quality management; Interact with internal and external auditors during compliance

audits; Provide support with the preparation of aggregate reports.

Alpha Scientific/CR Bard, Inc. 06/2013 –

8195 Industrial Blvd Covington, GA 30014 770-***-****

07/2013

Legal Adverse Event Reporting Specialist

Reviewed significant medical device adverse events litigation reports for completeness, accuracy and

appropriateness ; Evaluated complaints for determining mandatory Medical Device/MedWatch

Reporting and document rationale for filing US Food and Drug Administration regulatory MDRs;

Data entry of litigation complaints in the TrackWise database; Identified significant information

missing from initial reports and ensuring its collection; Generated and mailed information request

letters to attorneys; Ensured that all cases that require expediting reporting to worldwide regulatory

agencies are processed swiftly and appropriately within required timelines; Contacted investigators and

other reporters, to solicit comprehensive follow-up information; Documented communications with

contacts/requests for follow up information; Performed final review for closure of complaint files to

ensure accuracy, completeness; Creation of FDA MDRs ; Performed assessment of devices, adverse

event, medical history and concomitant Therapy; Coded all adverse event terminology, other medical

information, and Medical Device information utilizing FDA Codes; M aintained coding guidelines and

conventions; Conducted written medical review/assessment, Determined and performed follow-up

for missing, discrepant or additional information/source documentation for each case, and

document results in case file; assisted in the development of departmental or cross functional SOPs

and working guidelines.

SRA International/The Centers for Disease Control and Prevention

1600 Clifton Rd Atlanta GA 30333 404-***-****

11/2006–7/2012

CDC- Division of Select Agents & Toxins Executive Assistant 2011 – 2012

Provided contractor services through performance of administrative support to the Directors’ office:

Provided exceptional receptionist duties, typing, filing, copying, operating office machinery, data entry

services; Managed Leadership schedules utilizing Microsoft Outlook and SharePoint calendars; travel

preparer and point of contact for 15+ travelers, utilized GovTrip to process domestic/international travel

authorizations and vouchers for approval, processed VISA’s/Passports and travel training requests;

Established a filing system to avoid delay in providing requested documents, using record retention

policies, ensured security of classified information and records; Responsible for incoming and outgoing

mail for the Director’s office, reviewed outgoing/incoming documents for accuracy and completeness,

proper attachments and signatures; Generated working documents, correspondence, letters, memoranda,

and various order reports, SharePoint database management; Assisted the Event Coordinator with

preparation of materials for national workshops and conferences; Updated contact lists; Transcribed

meeting notes; Arranged meetings and provided the appropriate equipment and materials needed;

approved/disapprove conference room reservation requests; Processed visitor requests, POC for escorting

of visitors to/from the CDC Visitors’ Center; Ordered and maintained office supplies/reports; Reported

office equipment and building maintenance issues, to the proper department on a timely manner; Provided

coverage for absent administrative assistants; Provided 24/7 services during emergencies.

CDC/FDA- Vaccine Adverse Event Reporting Specialist 2008- 2011

Reviewed, investigated and analyzed reports and medical records for risk and adverse event

identification; Perform triage of incoming AE reports for classification, completeness, consistency and

seriousness; determine whether a product malfunction or serious injury reports needs to be filed with the

FDA; determine whether a 30 day or 5 day MDR report is required; prioritize and report per CDC and

FDA regulatory guidelines from national and international reports of (possible) adverse events that occur

after the administration of US licensed vaccines; supported the nurse follow-up team with case

management and medical transcription; performed continuous follow-up contact to

patients/parents/guardians, healthcare providers, coroners, state vaccine programs, and other

constituencies; answered questions pertaining to vaccine schedules and common side effects; reported

unusual vaccine trends; ensured FDA regulatory compliance with timelines for individual expedited case

reports and summary reports; ensured the quality of the medical records by verifying their completeness,

accuracy, and proper entry into VAERS database; abstracted and retrieved medical data used for

evaluation and research; prepared requests for medical records and send request via fax or mail; updated

VAERS database with all follow-up case activities; assisted managers with the planning and

implementation of HIS procedures/policies; developed reports, memoranda on job related activities;

provide advice to tech support on existing or proposed systems and strategies; adhered to CDC, FDA, and

HIPAA policies and procedures; assisted data-entry medical coding/records dept. with work overflow;

assisted with, interviewing, training, mentoring, and supervision of HIS staff.

CDC - Georgia State Dept. of Vital Statistics Records Manager 2010-2010

Provided records management of Death Certificates, according to Georgia State compliance policies, to

enable the CDC with appropriate access to the records; assisted with developing a records storage plan;

managed the changeover from paper to electronic records into CDC database; reviewed all records

following data capture to ensure documents’ quality and accuracy; created spreadsheets to store and

retrieve data, and created reports; advised staff in other departments on the management of the records

and information; maintained confidentiality and data privacy according to Federal and State laws.

CDC -DSAT Data Management Specialist 2008-2008

Processed laboratory access requests received for The National Select Agents Registry Program, which

oversees the activities of possession of biological agents and toxins; data-entered, validated,, and updated

identifiable information of the Responsible Officials and individuals who have access, or who have

applied to have access to select agents in accordance to the Code of Federal Regulations, using NSAR

database; checked in/out sensitive entity files for inspectors; ensured that all files were bar-coded

correctly.

CDC/FDA- VAERS Medical Coding and Data-Entry Specialist 2007- 2009

Perform Quality Control of reports identifying critical missing information and communicate

recommendations to processors on VAERS database; data entry of safety information, initial

determination of seriousness, expectedness, listedness, and USA FDA reportability; determining follow-

up activities. Data entered and coded serious and non-serious adverse events reports into VAERS

database; provided medical coding using MedDRA, ICD 9 and CPTs,; assigned and recorded an accurate

code to diagnoses, procedures, and operations as documented in the patients’ Multi-Specialty medical

records/reports’; obtained, researched, added/updated required information from affiliates; generated

reports of unusual trends; assisted with SOP updating; complied with telework rules.

CDC- Z-Tech Data Management Specialist 2007-2007

Input and validated national and international healthcare facilities grantee data for the CDC; provided

QA/QC of the data; converted 10,000+ PDF files to text readable files into database, before deadline;

recognized and performed problem resolution with project staff /manager; reorganized CDC’s file room

by creating filing system, labeling and arranging all files; developed and updated standard operating

procedures for quality control activities; ensured security of classified information and records.

CDC- Model Performance Evaluation Program (MPEP) Data Analyst 2006-2007

Accurately data entered data from national nurses’ surveys in regards to school sport s injuries; assisted

manager with editing and adjudications; processed enrollments/dis-enrollments and other change requests

for participating clients; Created and generated standard data reports using SAS program; Assured

information is accurate and perform analytical computations necessary to process data; provided routine

administrative and clerical support.

A Job for You, Inc. /CMD Realty 7791 Pines Boulevard Pembroke Pines, FL 30324 954-***-****

12/2004–11/2006

Commercial Property Manager Executive Assistant

• Assisted commercial property manager with, receptionist duties, mail/memo distribution,

composition of correspondence/ notifications/leases; maintained vendor and tenant lists; ordered

supplies; monitored and processed access key cards; monitored security system; ensured accurate

and timely billing and collection of monthly bills and other obligations from tenants, and taking

appropriate late payment and collection actions; maintained accurate accessible files and records;

created an SOP and guidelines processes; assisted property manager with corporate book keeping;

processed accounts receivable/payable invoices for assigned using Timberline and Lotus

accounting systems daily; assisted the property manager with all facets of building operations

including safety issues, incident reports, and insurance claims; reviewed work order reports

weekly; contacted vendors to schedule work in the building and in tenant spaces; performed

monthly building inspections; interfaced with tenants, brokers, vendors, and visitors; Interfaced

with current and future tenants, brokers, vendors, and visitors; provided o ffice manager coverage.

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Wise Optical Vision Group 4 Executive Plaza Yonkers, NY 10701 810-***-****

01/2000–01/2003

Customer Service/ Sales Representative

Received and process optical and contact lens sales orders, service requests; RMA’s and credits

according to existing procedures; monitored and analyzed the operating system for timely

transmission, shipping and invoicing of all order types; provided support on a departmental and

organizational level; provide proactive and resolution driven customer service; demonstrate

exceptional telephone and email manners and skills; Actively participated in all up selling; crossing

selling; branding efforts, programs and scripts supporting inbound and outbound campaigns for

Sales and Marketing departments; Responded to 200+ incoming calls per day, including voicemail;

faxes and emails positively and timely; entered new orders based upon customer’s

compliance/routing requirements; monitored open orders and returns for timely processing

through shipping; receipt; credit or refunds; provide general information regarding product

description; availability; pricing and lead time; logged all cancel /save transactions and submit

report to team leader weekly; follow up on credit card declines providing Dunning letters to

delinquent consumer accounts; coordinating with Finance for collection efforts when required;

daily research and resolution of orders transmitted from the web; notified new account leads to

Sales, investigated, analyze & resolve all inquiries to customer’s satisfaction; provided return

merchandise authorizations and received returned goods in accordance with existing procedures;

carried out full corrective action for returned merchandise; exchanges; credits and resolution to

any related issues; proactively communicated all concerns and issues to supervisor regarding

Consumer affairs inquiries (merchandise defects or damages and personal injury claims; worked

with third party logistics and service partners to expedite service and/or resolve customer issues or

inquiries.

TECHNICAL SKILLS

• Software: Microsoft Word, PowerPoint, Access, Outlook, Excel, SharePoint, TrackWise, Adobe

Acrobat/PDF, Electronic Data Capture, National Select Agent Registry, Vaccine Adverse Event

Reporting System, Avaya/Nortel/IP Soft phones, GovTrip

• Accounting Systems: Lotus Notes, Timberline, Quick Books, MediSoft

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MEDICAL SKILLS

• Ophthalmic, Vaccine, and Women’s Health FDA Adverse Event Reporting; Medical Terminology,

ICD-9/CPT10/MEDDRA medical coding, Medical Transcription, HIPPA

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EDUCATION

• Health Information Management Kaplan Online University 2014 -Present

• Medical Coding and Billing Certificate Penn Foster Career School Scranton, PA 2010 – 2012

• Quality Assurance/ Control Certificate US Dept. HHS University Atlanta, GA 2011

• Medical Records Transcription Diploma Penn Foster Career School Scranton, PA 2009- 2010

• Writing, Administrative, Business and, Microsoft Certificates SRA SkillsPort 2006-2012

• Registered Nursing College Credits Borough of Manhattan College New York, NY 1995-1999

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• References Available Upon Request

Contact this candidate