Medical Record Extractor

RESUME

RAJASHEKHAR REDDY PADMATI

Tel: 970-***-****

E-mail: ***************@*****.***

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OBJECTIVE:

Seeking for a position of Clinical Pharmacovigilance/Drug Safety

within the pharmaceutical/Biotechnology/CRO environment by contributing my

knowledge and skills of Clinical and Pharmacovigilance with accuracy

towards the growth of organization and professional growth to my career.

SUMMARY:

. 3 years of experience in preclinical and Drug safety, with 2 years in

pharmacovigilance and 1 year experience in pre-clinical in-vitro

studies.

. Detail oriented case processing includes Safety Review, Triage, Data

entry, Quality review, Duplicate Searches and follow-up in accordance

with FDA and ICH guidelines.

. Review of SOP's accordance to company standard procedures.

. Assist in daily workload with Safety Manager and Medical Records for

daily metrics and other relevant safety documentation.

. Medical Literature review and follow- up of AE/SAE's in compliance

with domestic and global safety regulations.

EXPERIENCE:

Jul 2011-Sep2012

Position: Medical Records Extractor Bayer

Health Care

Pharmaceuticals

Responsibilities: Wayne, NJ

. Case prioritization based on seriousness of adverse events in

accordance with Bayer SOPs (Standard Operating Procedures) and

regulatory guidelines.

. Reviews medical record follow up to cases in litigation in accordance

with US FDA Regulations.

. Analyzes and extract pertinent information from medical records in

accordance with legal and US FDA safety regulations.

. Creates comprehensive narrative procured from relevant legal case

documents and medical records as determined by regulatory and Bayer

SOP guidelines.

. Data enters relevant information from completed extraction form from

MRT or CRO (Clinical Research Organizations) into Argus LAM

. Reviews Legal Complaints and/or Summons and case entry into Argus

Local Affiliate Module (LAM)

. Responsible for closing action items to cases in litigation.

. Identifies and follow department procedures for AEs associated with

product complaints.

Position: Legal case Safety Data Specialist Bayer Health

Care

Pharmaceuticals

Montville, NJ

Responsibilities:

. Reviews case information to ensure all criteria are met to create a

case.

. Triage and prioritization of legal cases and medical records based on

seriousness of adverse events in accordance with Bayer SOPs (Standard

Operating Procedures) and regulatory guidelines, and assign for

extraction in medical record repository (Documentum).

. Identifies and follow department procedures for AEs associated with

product complaints.

. Communicates with External Legal Partners to ensure timely

transmission of information and clarification of patient data as

needed.

. Initializes or add as follow up all Extraction Forms (EFs) received

from external extraction CRO sent to USPV MRT for processing.

. Supports Legal Case Safety Data Assistants as needed in the following

functions, according to business needs:

a. Perform Argus LAM and Documentum Quality Assurance of Data

Fields as necessary for accuracy.

b. Updates of Extraction Tracker with extraction data as confirmed

by Documentum.

c. Reconciliation with Extraction Contract Research Organization

(CRO) of extraction forms sent from CRO to Bayer USPV MRT.

d. Upload and transmission of data via electronic gateway.

e. Monitor USPV MRT Mailbox and upload incoming potential legal

cases in Documentum.

f. Upload of Legal Medical Records, completed extraction forms, and

Incoming Legal Cases into Documentum.

Bayer Health Care

Position: Safety Data Specialist Pharmaceuticals

Montville, NJ.

Responsibilities:

. Serve as primary role for triage and case prioritization based on

seriousness of adverse events appropriate with company SOP's

(standard operating procedures) and regulatory guidelines.

. Identify cases where supplemental or clarifying information is

needed and notify the call centre specialist to obtain this

information.

. Initialize or enter follow-up information into the Argus affiliate

database, ensuring each case is unique, avoiding duplicate

reporting to the FDA by performing accurate duplicate checks.

. In conjunction with the Life Cycle Manager, determine whether cases

need distribution against distribution rules, appropriately

distribute to authorities through the Argus affiliate database, and

perform post-distribution check.

. Perform reconciliation with licensing partners and CRO's to ensure

compliance and accurate receipt of all adverse events information.

. Serve as mentors to the Safety Data Associates and Safety Data

Assistants, assist in the management and training of Safety Data

Associated in interpreting and entering serious and non-serious

adverse events into the Argus affiliate database.

. Verify, as prescribed by regulatory guidelines, that trade names

are correctly translated into INN (International Non-proprietary

Name)

. Identify and follow department procedures for AE's associated with

product complaints.

Oct 2009-Dec 2010 Pharmalynx

Position: Drug Safety Associate Princeton,

NJ.

Resposibilities:

. Drug safety monitoring by optimizing scientific quality documentation.

. Data Entry and Quality Check of Individual Case Safety reports (ICSRs)

in Pharmacovigilance database (ARGUS) and other case management

activities such as check and remove duplicate entries.

. Data entry of AE and SAE's in line with MedDRA terms.

. Writing of case narrative.

. Perform review and evaluation of case reports for completeness and

accuracy.

. Follow-up of serious and non-serious cases in accordance with FDA/ICH

regulations.

. Literature Searches and Literature Reviews.

. Review of SOPs.

. Execution of Company Standard Operating Procedures.

. Management of Compliance with the Company Standard Operating

Procedures and regulatory requirements.

. Maintain awareness of changes to/new regulations affecting

Pharmacovigilance activities. Communicate new or changed regulations

to management and to relevant members of the department in order to

initiate any change in processes.

. Manage daily workload in conjunction with Pharmacovigilance Manager

and Medical Affairs for individual case processing, case reporting and

any other tasks relevant to the Pharmacovigilance Department.

June 2008-Aug 2009 Mount Sinai Medical

Center

Position: Research Assistant New York, NY

Defended Thesis on Cardiac Calcium Channel Regulation (8/20/09)

Mount Sinai Hospital, Annenberg Building, Pharmacology and

Systems Therapeutics.1468 Madison Avenue, New York 10029. Under

the guidance of Dr. Maria Diverse Associate Professor

Pharmacology and Systems therapeutics department.

Aim: To visualize and analyze the protein-protein networks

generated by the activation of the IGF-1 and the beta-adrenergic

receptor in cardiac cells.

System: Acute adult rat cardiac myocytes

Methods: Insilico approach were we have built up a literature

based protein-protein interactions list by using various

software and online databases such as HPRD, Genecards, PUBMED

and software such as SAVI is a software system used to detect

and visualize the network motifs in cellular signaling pathways.

Also we have performed the bench level Protein Assay,

Immunoprecipitation, Protein western blots, SDS-Page, ECL

reactions.

Hypothesis: Our hypothesis is that IGF-1 acts as an ionotrope in

heart by regulating voltage-dependent calcium channels

through PI3K and SRC kinase activity.

Aug 2006-Dec 2006 Mediland Transtech

Position: Medical Transcriptionist Hyderabad,

India.

. Transcription of medical prescriptions for M.D's.

Jan 2005-May 2006 UNI-SANKYO Limited

Position: Clinical Drug Safety Hyderabad, India.

. Collection and maintain Case reports.

. Compilation and documentation of safety Data Analysis.

. Data entry, Data Analysis and Familiar with report writing.

. Statistical Analysis

PRE-CLINICAL & CLINICAL SKILLS:

ELISA Assay, Protein Assay, Immuno-precipitation, Protein

Western blot's, SDS Page, ECL reaction, Insilico and Biochemical

approach, Cell and Tissue Culture Techniques, Pipetting, RT-

PCR. Familiar with HPLC.

Analytical Techniques: Proficient with pH Meter, Analytical

balance,

UV-VIS spectrophotometer, Acid-Base Titrations.

Knowledge of SOP's, GLP,GCP, ICH, FDA and Regulatory guidelines.

EDUCATION:

. Jan 2007-Aug 2009

Long Island University C.W. Post, Brookville, New York.

Completion of Master's of Biomedical Sciences (Immunology)

. Oct 2002-May 2006

Osmania University, Hyderabad, India.

Completion of Bachelor of Pharmacy (B.Pharmacy) Degree

ACCOMPLISHMENT'S:

. Participated as Student Volunteer at the 57th Indian

Pharmaceutical

Congress (IPC) India: Nov 2005 and Awarded a certificate of

appreciation.

COMPUTER SKILLS:

. Complete Microsoft Office Suite

. ARGUS Safety Database and MedDRA coding dictionary.

. SAVI, Gene2network, Statistical analysis.

. Pdraw 32 DNA cloning, primer design.

. Familiarity with Clinical SAS 9.1 programming.

. Learning software used in Risk analysis.

Contact this candidate