Medical Data Entry

GYPSON JOLLY

Mobile:- 201-***-****

Email:***************@*****.***

Summary:

Minimum 5 years of experience in the clinical trial industry as a Drug safety associate

with Pharmaceutical and CRO companies.

Excellent computer proficiency including EDC and MedDRA.

In-depth knowledge of International Pharmacovigilance requirements, US FDA, EMEA

requirements/international guidelines, ICH/CIOMS.

MedDRA 16.0, Adverse Event Reporting System (AERS) to monitor serious adverse

events.

Incredible research aptitude with vast academic knowledge.

Extraordinary ability to problem solving and good documentation skill.

Aptitude to recognize and appreciate with cultural differences.

Efficient computer skills with demonstrated experience in working with the Microsoft

office (Word, Excel, PowerPoint, and Outlook).

Reliability in protecting confidential information.

Ability to perform effective judgment in recognizing scope of authority.

Excellent with Professional verbal/written communication skills.

Ability to Obtain and Process Information.

Able to analyze quantitative data.

Good communication, Conflict management skills.

PROFESSIONAL EXPERIENCE

TAKEDA DEERFIELD, IL

PHARMACOVIGILIANCE SPECIALIST June 2012 to

August2014

Received and reviewed adverse event forms for completeness, recognizes discrepancies,

enters data into ARISg safety database, obtained follow-up information and assessed

causal relationship of event to company drug.

Generated medical narratives derived from the collection of adverse event information

and verified medical coding in the safety database system.

Identified methods to improve quality of safety data. Assisted in the design and

implementation of safety data management processes to ensure completeness, correctness

and consistency of safety data.

Generated and sent data queries with clinical database EDC (Medidata Rave).

Participated as Pharmacovigilance expert in the Global Safety Teams for designated

products.

Worked on SAE reconciliation to check information, and ensured it matched in both

clinical and safety database. Provided data correction if needed.

Triaged incoming cases to determine seriousness for prioritization of daily workflow.

Represented pharmacovigilance department internally and externally at a global level and

functioned as an authoritative and professional member of relevant teams.

Assisted medical reviewer in QC and reviewed case narratives for other colleagues and

other team members and also assisting in issuing sponsor query in medical point of view

by utilizing my medical knowledge.

Led signal detection/safety monitoring activities for pharmacovigilance operations.

Reviewed safety reports for accuracy of data and MedDRA and WHO coding.

Worked on data correction, lab review, and non-product compliance.

DRUG SAFETY ASSOCIATE

GILEAD SCIENCES, FOSTER CITY, CA March 2011 to

April 2012

Perform triage of incoming cases to determine seriousness for prioritization of daily work

flow and performed search for duplicate cases.

Document classification of Adverse Drug Event (ADE) reports according to the

following criteria: source, serious and non-serious, data entry priority, initial vs. follow-

up report.

Utilize safety databases to log, track, prioritize, and to respond to product complaints and

serious adverse events (SAEs).

Enter initial and follow-up information for individual AE case reports onto

the Drug Safety database in accordance with the current Data Entry and Process

Instructions and associated SOPs.

Self QC (Quality Check/Control) of entire case to see consistency between source

documents, and verify narrative summery and medical coding, before transferring for

Medical Review (MR).

Review each AE/SAE report for accuracy, completeness, and consistency.

Composition of concise, accurate and well written safety narrative for different cases.

Perform Consistent MedDRA and WHO Drug coding of diseases, adverse events, and

medications using different search options (e.g., like, full, or wild card).

Create and maintain project-specific working files, case report files and project central

files.

JUNIOR RESEARCH FELLOW (JRF) July 2010 to

Dec 2010

PUSHPAGIRI RESEARCH CENTRE, TIRUVALLA (PATHNAMTHITTA DISTRICT).

Worked on wound healing (Ulcer (Diabetics Ulcer, Blood Pressure & Venous Ulcer)

Burn Patients ) treated with Poly actic acid Membrane with 95%Successfull Rate in

Research.

Worked on data correction, lab review, and non-product compliance.

Review each AE/SAE report for accuracy, completeness, and consistency.

Clinical Research Coordinator Trainee (CRC)

HEALTH &RESEARCH CENTRE (HRC), TRIVANDRUM. Nov 2009 to

June 2010

Learning Outcome:-

Patient Registration, Demography, OP Book Dispensing, Inform consent process, Interactive

Voice Response System(IVRS), Interactive Web Response System (IWRS), Electronic Data

Capturing, Data Replication, Electronic –Case Report System, Council for International

Organization of Medical Sciences, Drug Compliance, Lab Procedures etc.

VOLUNTEER EXPERIENCES

Organized and participated in Medical camp and Blood donation camp.

Organized a National Seminar on CLINICAL RESEARCH & CLINICAL

DATA MANAGEMENT hosted by Mir IFCR in association with KREARA.

Active member of Literary Association conducted by Mir IFCR.

Participated in technical fest and seminars conducted inside and outside the

college.

ACTIVE MEMBERSHIPS

Member of National Cadet Corps (NCC) 15K Battalion.

Member of Red Cross Society.

PARTICIPATION

Specialized training in Clinical Research Method and Design lead by

Dr.Hari Dayal, PhD Adjunct Professor, University of North Texas, USA.

A workshop on “Regulations Meet Practice and Advanced GCP” hosted by Amrita

Institute of Medical Sciences and Research in collaboration with Pfizer.

Training on SAS Software.

Participated in the seminar on clinical research and clinical data

Management conducted by MIR IFCR in associated with KREARA and led by the

scientific advisory board of MIR IFCR at Cochin.

Pharmacovigilance by Dr. Santhosh Joseph, MD (Pharmacology)

Sree Mookambika Institute of Medical Sciences, Tamil Nadu.

EDUCATIONAL QUALIFICATIONS

MASTERS IN CLINICAL RESEARCH & REGULATORY AFFAIRS, MIR-IFCR

INSTITUTE AT COCHIN AFFILIATED TO CAMPBELL UNIVERSITY, USA.

BSC BIOTECHNOLOGY WITH COMPUTER SCIENCE,

UNIVERSITY OF DEVI AHILYA VISHWA VIDHYALAYA. (DAVV)

Contact this candidate