Medical Assistant
Resume:
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