Medical Quality

SOUMYA.B

Sai Raghava Enclave, D-Block, Flat no. *09, Near Sridevi Theatre, Chanda

nagar, Hyderabad-500055

Contact No: 994-***-****, 924-***-****, Email: ***********@*****.**.**; DOB:

8th Mar 1982

ASPIRING CLINICAL RESEARCH & ANALYSIS PROFESSIONAL

OBJECTIVE: Targeting research industry, seeking a challenging assignment in

the clinical research and analysis with multi-faceted competencies seeking

to delve in the areas of medical research portfolios to shoulder broader

responsibilities, thereby attaining career advancement.

PROFILE

. Competent and consummate professional with demonstrated potentials of 7.6

yrs. in Transcription, Medical Coding, Scientific writing (includes Phase

I clinical data annotation) with Team Management and streamlining quality

operations & controlling & coordinating in the product improvement

activities, while constantly propelling the team & individuals to achieve

service excellence along with organizational objectives and well trained

in handling the gamut of functions related to Clinical Trial Process;

Clinical Trial Design; Ethics & Good Clinical Practice; ICH-GCP

Guidelines.

. Analytical & detail-oriented, with tremendous comprehension of medical as

well as clinical data terminologies coupled with well-honed expertise in

indexing and abstract writing. Have undergone intensive corporate

training (how to give an effective feedback, quality awareness,

presentation skills, time-management skills etc) in reporting of whole

team performance based on proficiency, quality, and utility to the

managers, which aids mainly in intensive calculations.

. Seasoned professional, with planning, monitoring & resource-balancing

skills & ability to handle multiple functions in high pressure

environments, offering expertise in deciphering the true impact of any

strategic decision with exceptional clarity while communicating the

requirements & deliverables to the team members.

. Multilingual with proficiency in English, Telugu & Hindi.

Core Competencies: Strong Medical Base( Leadership/ Training ( Project

Management

IT Proficiency( Relationship Management( Target Achievement ( Quality

Controller ( Quality Management ( Time-management(

PROFESSIONAL CHRONICLE

MEDICAL WRITER

Primo Scientific Corporation, Hyderabad, December 2010 - Till date

Responsibilities:

. Responsible to produce abstracts, short communications, manuscripts,

review articles, global medical slide sets, study slide sets,

manuscript slide sets (PDF, MS-PowerPoint & Word), slide sets for

posters, slide set for oral presentations at scientific congresses,

and other written communication material supporting pharmaceutical

brands, research activities, and business needs.

. Responsible for the planning, writing, editing, reviewing, and

coordinating the publication of clinical data to peer-reviewed

journals.

. Responsible for the tracking, quality control and timely completion of

the document components for complex medical writing projects.

. Working together with key client counterparts at clients locations to

facilitate the completion of project and their appendices.

Understanding new agreements and changes due to SOPs and regulatory

guidelines.

. Hands on experience in using DataVision tool for medical documents

storage.

. Trained in writing regulatory documents such as CSRs (Clinical study

reports), IBs (investigator brochures), Protocols, informed consent

forms according to the ICH-GCP guidelines.

. The use of several advanced project estimating, forecasting, and time-

tracking mechanisms has facilitated a successful track record of

delivering client services in a timely, thoughtful, and professional

manner.

. Excellent project management and clear understanding of the guidelines

of various regulatory bodies.

. Strong skills in areas of medical writing and also analytical and

research skills.

. THERAPEUTIC AREAS: Areas include cardiology, oncology, endocrinology,

neuroscience, osteoporosis, urology, osteoarthritis, women's health,

and health outcomes.

. Hands on experience on editing tools like Snagit, Adobe photoshop, and

Visio. Graph tools such as Prism and Sigma plot.

TEAM LEADER

Thomson Reuters, Hyderabad, Jul 2007 - December 2010

Responsibilities:

. Challenged to lead a team for BIOSIS (scientific analyst) which works

for scientific journals, patents, and research articles, and writing

abstracts for a wide variety of articles (like case reports, review

articles, news reports etc).

. Carrying out analysis of the research journals and give the client who

are using the site with accurate information within a small time.

. Daily reporting of team performance to the QC of Ireland, attending

the conference calls with the external QCier's of Ireland to clarify

the emerging toughest doubts of team members.

. Conducting the meetings and seminars to improve the performance of

team members.

. Taking care of employee attendance reports, quality score reports to

estimate the individual incentives.

. Giving training based on the process for the individuals who are newly

employed and assessing their knowledge on the process by conducting

test, and mock practice sessions.

. Estimating utility, proficiency and quality of individuals to improve

the collective team performance.

. Analyzing the area of mistakes of analysts (through Pareto-analysis)

and giving them feedback regarding their errors in turn reducing the

errors.

. Responsible for training new hires in BIOSIS process. Effectively worked

with a team spirit of 25 members in producing an error-free high standard

quality product. Good maintenance in task planning, maintaining the Qs,

timely submissions of reports to the reporting manager.

. Maintaining the required team quality by identifying team hurdles in

terms of quality and troubleshooting through Pareto analysis, fish bone

analysis(Ishikawa or cause & effect diagram), control charts.

Process improvement:

. Introduced QC database, which made the indexers to work comfortably

and has been using as process reference source.

. Introduced web-based queries database which can be accessed by all the

team members for the queries and replies from the hub on a single

platform to avoid discrepancies in communication among us.

. Additional options on the Pegasus toolbar which will help the team to

concentrate at those portions where they are lacking and thereby save

the production time.

. Helped the team in giving indexing tips, setting up a medical

terminology document which can be used on a daily basis.

. Explained the team the actual workflow of the process.

MEDICAL CODING EXECUTIVE

Medical Billing Executive

Apollo Health Street, Hyderabad, May 2006 - Apr 2007

Responsibilities:

. Hired to ensure correct calculation and preparation of bills related

to insurance of patients and submitting them to their insurance

providers

. Coordinated various activities with the departments of Pediatrics and Ob-

Gyn for completing the billing

. Assigned to work on ICD-10-AM platform related to Medical Coding

adapted from Australian using MedDRA (medical dictionary).

. Educating executives the importance and use of the medical coding and

R&D on lab procedures

. Actively involved in the quality check for all the work processed by

the executives.

MEDICAL TRANSCRIPTIONIST

Transdyne IT Solutions, Hyderabad, June 2005 - May 2006

. Assigned the task of transcription of the files submitted by the doctors

in the U.S.A, related to the cases from different patients.

. Responsible to transcribe the file containing diagnosis and treatment,

case studies of the whole disease and therapeutics.

Achievements:

. Applauded by the management for the excellent work done in the

Departments of Medicine on Cardiology, Gynecology, Neurology,

Gastroenterology and Orthopedics

ACADEMIA & PROFESSIONAL CREDENTIALS

M.Sc Biotechnology

Vel's College of Science, Chennai, Madras University, 2004

B.Sc (MicroBiology, Biochemistry & Chemistry)

Nagarjuna University, 2002

Diploma in CRA (Clinical Research Associate)

UBNQtech, Hyderabad

Currently pursuing MBA from Symbiosis, Pune.

Diploma in Medical Writing from InfocusRx, Hyderabad.

Computer Skills:

. Proficient with the use of Windows, MS-Office (Microsoft certification in

MS-Excel) and the Internet

. Experience in working with image capturing tool, SnagIt and documentation

tool, Adobe professional documentation tool.

. Skilled in C-Language, Oracle 11i (PL/SQL), SAS (SAS Clinical Trials,

BASE/ SAS, SAS /PROCEDURES SAS/ MACROS, SAS/ACCESS, SAS/CONNECT,

SAS/STAT).

Project Presentation:

. Worked on a project in Dr.Reddy's, which is based on Quality and

Control related "Pharmaceutical MicroBiology".

. Presented "Human Genome Project" in an Intercollegiate Seminar conducted

by Vel's College of Science.

Reference: Would be made readily available on request.[pic]

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