Project Manager Medical

Jeffrey L. Lewis, R.Ph.

**** ***** ****

Annapolis,Maryland 21403

Home Phone: 410-***-****

Cell Phone:443-***-****

E-Mail:**********@*****.***; **********@*****.***

Computer and Database Skills :

Oracle Clinical Databases, Who-Drug, Who-Art, Co-Start, MedDRA Coding

Experience, TMS(Thesaurus Management System) Cerner's DS Navigator and DS

Explorer

Clinical Experience: Worked as a Night Pharmacist at North Arundel Hospital

from 9/1986-3/1990, Worked as a Pharmacist in a Nursing Home Facility from

9/1986- 3/1990, Worked as a Pharmacy Manager for Drug Emporium in Tampa,

Fla from 3/1990 to 7/1991.

Experience

Heitech, Inc., Landover, Md.

Drug Safety Analyst / MedDRA Coder January 2011- Present

. Responsible for analyzing Adverse Event Reports submitted to the FDA by

pharmaceutical companies, pharmacies, health care facilities, and

consumers

. Verified and ensured all information was accurate, prior to sending to

FDA, on MedWatch 3500, MedWatch 3500A, Form 1639, and CIOMS Forms-

Foreign

. Ensured accuracy of information on Periodic Reports, 15-day Expedited

Reports, and Direct Reports

. Received extensive training and coding experience with Who-Drug, Who-

Art, Co-Start and MedDRA Coding

. Served as a Drug Information and Drug Safety resource person on Clinical

Development Teams.

. Supervised the activities of other Drug Safety personnel

. Performed QA/QC on the electronic submissions submitted into AERS

through the FDA

. Processed Serious Adverse Events from clinical trials.

. Ensured FDA and International Regulations (ICH) were followed regarding

clinical trial drug safety

. Validated reports were accurate, consistent and completed in a timely

manner

. Conducted database management for Oracle Clinical and ClinTrace for a

Princeton, NJ client

. Set up standards and SOPs for assigned drug projects (i.e. updating and

tuning the Drug Database)

. Identified resource needs and timelines

. Developed and coordinated Safety Surveillance Procedures

. Formulated Safety Surveillance Policies and Procedures when ensuring

corporate compliance with Adverse Event reporting requirements

. Conveyed and acquired drug information to and from internal and external

customers

. Contributed to the Medical Information Database; removed redundancy and

corrected the validation of the drugs

. Provided feedback to Medical Coding Team regarding relevant medical

quality issues and facilitated the implementation and training of new

quality processes

KAI Research, Inc., Rockville, MD

Drug Safety Associate/Medical information Specialist May 2010- January

2011

Permanent Employment

. Addressed questions about products from two different Pharmaceutical

Companies

. Investigated and evaluated case reports associated with the safety of

investigational and marketed drugs

. Reviewed the published medical literature for reports of adverse events.

. Coded adverse drug experiences and other events using the MedDRA coding

dictionary

. Prepared expedited and periodic safety reports for submission to the Food

and Drug Administration

. Helped in the development of Risk Management Plans (RMPs) for the

products we were doing the Drug Safety with Dr. Reddy

. Helped to development of standard operating procedures for core safety

surveillance processes.

. Maintenance of safety files and documentation that are compatible with

the corporate document management system.

. Review of product and class safety information including pre-clinical,

clinical and post-marketing data from internal and external sources.

. Solid knowledge of applicable domestic and international safety reporting

requirements

SRA International, Inc., Rockville, MD

VAERS Project

MedDRA Coding Specialist/Health Info. Specialist November 2009 - May 2010

6 month Contact

. Performed MedDRA Coding on various types of reports for Vaccines

. Performed Follow-Up on Cases that needed to get to the Medical Records,

Discharge Summary, ER Records, Primary Care Physician's Records, and

Consultant Records (Health Information Specialist)

. Performed Data Entry Duties when needed

. Performed Receipt and Control (QC Documents into an Access Database)

CTS (Computer Technology Services), Rockville, MD FAERS PROJECT- 1st Stage

Pharmacovigilance Subject Matter Expert /Trainer May 2008 November- 2009

. Prepared and coordinated reviews of individual Case Safety Reports, as

well as Aggregate Safety Data, such as: Data collection, review,

analysis, interpretation and report preparation on (a) safety-related

information (b) product literature, (c) epidemiology of health and

disease; and (d) adverse event data from safety databases

. Performed investigation, analysis, interpretation and report preparation

subsequent to review of safety alerts and trend reports from post-

marketing safety databases

. Assisted with organizing and running searches of safety and regulatory

databases

. Supported related Pharmacovigilance activities such as preparing reports

for surveillance, collating reports for review of product quality data,

support of health hazard evaluations

KAI Research, Inc., Rockville, MD

Drug Safety Associate/Medical information Specialist February 2008- May

2008

3 Month Contract

. Addressed questions about products from two different Pharmaceutical

Companies

. Investigated and evaluated case reports associated with the safety of

investigational and marketed drugs

. Reviewed the published medical literature for reports of adverse events.

. Coded adverse drug experiences and other events using the MedDRA coding

dictionary

. Prepared expedited and periodic safety reports for submission to the Food

and Drug Administration

. Revised pharmaceutical product labeling

. Worked with Drug Safety Database ARISg

. Produced Medical Information for Clients and Patients

Telesis Corporation for CFSAN, College Park, MD

MedDRA Coder/Drug Safety Review Specialist November 2005 - February 2008

Assistant Project Manager (FDA Level 5 clearance)

. Received incoming AE reports, performed initial review, coded clinical

symptoms using MedDRA dictionary, performed data entry and executed final

sign-off on data entry

. Drafted and updated SOPs as needed and supported project management

activities

. Set Up Training Module for MedDRA Coding and TMS for Telesis for the

employees in Data Entry

. Trained users for MedDRA coding and TMS for drug companies in the United

States

. Reviewed medical records for verification of reported events; encoded AEs

using MedDRA and queried sites for clarification

. Functioned as point of contact for technical questions

. Generated match and no-match reports of coding data to review for

accuracy and consistency of coding according to client and company coding

guidelines

Baxter Healthcare, Inc. Deerfield, IL

Senior Safety Review Specialist April 2005-November 2005

6 month contract

. Was the Global Training Specialist for MedDRA Coding and Who Drugs for

the divisions throught Asia, Europe, South America and United States.

. Post-market products consisted of Medication Delivery, Renal, Biologics,

Anesthetics, Critical Care and Oncology (Breast CA, Prostate)

. Performed safety review and analysis of AEs for assigned clinical and

post marketing products, including triage, review, narrative writing,

query generation and tracking, interface with reporters/investigators,

etc.

. Interfaced with medical reviewers on AEs and other safety-related issues

. Interfaced with regional country organizations in processing AEs and

other safety-related activities

. Participated in and oversaw literature review activities related to AE

reporting as well as safety reports (e.g. Periodics, PSURs) writing

. Interfaced with company groups as needed, including Quality, Regulatory,

Informatics, and Business units

. Participate in and oversaw call-center activities related to adverse

event reporting

. Prepared safety submission documents (expedited reports, annual reports,

briefing documents, etc.)

. Experience with commercial safety databases

. Utilized knowledge of various coding dictionaries, including MedDRA,

WHOART, and COSTART

. Worked on revising the product labels for various products that Baxter

makes

PSI International, Inc., Rockville, MD

Drug Safety Analyst / MedDRA Coder August 1999 - April 2005

. Responsible for analyzing Adverse Event Reports submitted to the FDA by

pharmaceutical companies, pharmacies, health care facilities, and

consumers

. Verified and ensured all information was accurate, prior to sending to

FDA, on MedWatch 3500, MedWatch 3500A, Form 1639, and CIOMS Forms-Foreign

. Ensured accuracy of information on Periodic Reports, 15-day Expedited

Reports, and Direct Reports

. Received extensive training and coding experience with Who-Drug, Who-Art,

and Co-Start Databases

. Served as a Drug Information and Drug Safety resource person on Clinical

Development Teams

. Supervised the activities of other Drug Safety personnel

. Performed QA/QC on the electronic submissions submitted into AERS through

the FDA

. Processed Serious Adverse Events from clinical trials

. Ensured FDA and International Regulations (ICH) were followed regarding

clinical trial drug safety

. Validated reports were accurate, consistent and completed in a timely

manner

. Conducted database management for Oracle Clinical and ClinTrace for a

Princeton, NJ client

. Set up standards and SOPs for assigned drug projects (i.e. updating and

tuning the Drug Database)

. Identified resource needs and timelines

. Developed and coordinated Safety Surveillance Procedures.

. Formulated Safety Surveillance Policies and Procedures when ensuring

corporate compliance with Adverse Event reporting requirements

. Conveyed and acquired drug information to and from internal and external

customers

. Contributed to the Medical Information Database; removed redundancy and

corrected the validation of the drugs

Commercial Side - as needed ( Part-Time)

Performed Quality Control of received data from various VA Hospitals and

sites.

Perform MedDRA Coding of Adverse Events in narratives, indications and

medical history

Performed MedDRA coding for Pharmaceutical Companies: Bristol-Myers Squibb,

Pfizer, Pharmacia-Upjohn, and Schwarz.

Converted a legacy system to MedDRA v. 6.1 - transforming legacy terms into

MedDRA code (later updated to MedDRA 7.1).

Team Lead / Quality Assurance Analyst Drug Safety

Ensured ongoing improvement of data management systems and processes.

Resolved discrepancies between similar data recorded by two independent

sources to ensure the accuracy of data entered into critical fields.

Supervised medical professionals (Pharmacists and Nurses).

Assigned reviews of Adverse Event Reports and monitored the progress of the

reviews for completeness, on time and within budget.

Functioned as a resource/advisor for staff.

Quality Assurance Analyst

Applied in-depth knowledge of Federal Regulations to review documents

submitted to the FDA by physicians, pharmacists, and consumers regarding

all medications.

Ensured the accuracy and completeness of documents; referred incomplete or

inaccurate documents to the Risk Assessor for correction.

Accessed the Adverse Event Reporting System, an Oracle database, utilized

by the FDA to electronically process Adverse Event Reports to determine the

potential hazards of both pre- and post-marketed pharmaceuticals.

Worked with AERS (Adverse Event Reporting System), an Oracle database,

which is utilized by the FDA to electronically process Adverse Event

Reports (AEs) to determine the potential hazards of both pre- and post-

marketed pharmaceuticals for the MedWatch program.

Medifacts International Inc., Rockville, MD

Regulatory Affairs Analyst Part-Time Position January 2001- June 2001

Substantiated all documents for accuracy, including Investigator's CV,

Investigator's Medical License, Protocols, and Protocol follow-ups.

Performed QA/QC on reports and CRFs for a Phase II and Phase III

cardiovascular study

Set up Excel Reports for CRAs, RAs, and Safety Monitors.

Updated and developed new SOPs and performed Regulatory submissions.

Confirmed that Safety Monitors were verifying they received all the

information in their visit reports.

Corresponded with the FDA regarding all the procedures that needed to be

implemented.

Ensured regulatory programs and submissions met domestic and international

regulatory requirements.

Developed spreadsheets for each site regarding information needed to

maintain compliancy.

Acquired and utilized a working knowledge of FDA regulations and guidelines

pertaining to ICH.

Reviewed clinical investigation-relation documents for accuracy and

compliance with Good Clinical Practices.

Provided assistance to the Medical Monitors in examining Non-Serious

Adverse Events.

Prepared and reviewed IND safety reports, consent forms, safety sections of

protocols, CRFs and study reports.

Certifications

Completed the Fundamentals of Good Documentation Practices

Maintaining Confidentially/HIPAA

Completed Good Clinical Practice Thru KAI Research

Training for Drug Safety Signalling

Education

B.S., Pharmacy and Chemistry, Albany College of Pharmacy, Albany, NY 1976

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