Chakshu Desai, M.D.

Edison NJ *****. Ph. 732-***-**** Email:

drchakshu

@gmail.com

Summary

M.D. with 5+ years of pharmaceutical industry experience.

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Dedicated professional with training and skills in various areas of Clinical research

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& Drug Safety

Solid understanding of ICH and GCP with understanding of clinical trial

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methodology and logistics

Detailed knowledge of safety processes & working knowledge of scientific terms &

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medical terminology

Knowledge of database management & use of coding dictionaries (MedDRA and

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WHO DD)

Self directed with demonstrative record for working well both independently and as

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a team member

Knowledge of operational pharmacovigilance activities

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Well organized and highly detailed oriented computer proficient

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Highly organized approach and multi tasking

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Professional Experience

Pharmacovigilance Scientist Aug 2011 –

present

Contractor Otsuka Pharmaceuticals, NJ

Responsibilities

• Provided technical and process related support to Drug safety Management

(clinical Trial and post marketed) and medical monitoring activities, ensuring

compliance with relevant regulations and Standard Operating Procedures

• Prepared and reviewed queries to obtain critical or missing serious adverse events (SAE)

information for appropriate medical assessment

• Managed electronic and hard copy document management, retrieval, and archiving of PV

information including ICSRs

• Assisted with data-lock reconciliations and ensure all cases are complete and all

outstanding queries are resolved and closed

• Ensured accurate data entry and the timely processing of adverse event reports including

writing meaningful case narratives.

• Created queries for adverse event report clarification.

• Tracked adverse event information and prepared administrative reports for management.

• Assisted in developing and maintaining standard global procedures and guidelines for

Drug Safety operations.

• Reviewed, evaluated and assess adverse event information for regulatory reporting.

Clinical Study Scientist Aug

2009 – July 2011

Contractor Sun Pharma, NJ

Responsibilities

Ensured that all study activity is in accordance with standard operating procedures,

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FDA regulation

Good clinical practice and instructions/specifications outlined in the research

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protocol

Coordinated and conducted patient care visits and assured all procedures are

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conducted in compliance with the clinical protocol

Performed medical monitoring of study data, ensuring appropriate input from

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clinical research Physician, research specialist and staff

Coordinated contract approval process and track investigator payments

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Distribute SAE information to sites according to ICH/GCPs

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Worked with a dedicated team of research coordinators and other health care

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professionals for the completion of the study

Coached investigators to ensure optional compliance and performance, regulatory

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requirements, discrepancy reporting or ethical practice issues

Management of Case Report Forms and organization of protocols

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Recorded medical and clinical data in accordance with FDA procedures and

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regulations

Medical Assistant Jan 2007 – Jul

2009

Premier OBGYN, Somerset NJ

Pharmacovigilance Physician Mar 2004 –

Mar 2005

Themis Medicare

Professor of Anatomy Feb 2003 –

Feb 2004

MGM Medical College, Mumbai India

Skills

Proficient with MS Word, Excel and Power Point

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Working knowledge of Quick books

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Expert in Medi soft

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Expert in doctor’s notes

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Education and Certification

Bachelor of Medicine & Bachelor of Surgery (M.D.) Dec 2002

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Mahatma Gandhi Mission (MGM) Medical College Mumbai India

Certified Clinical Research Associate Sep 2008

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Certified Medical Writer Jul 2009

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Contact this candidate