Medical Data Entry
Resume:
Nadia Chowdhury
**** ****** *****, ******* ******* IL 60194
*************@*****.***
OBJECTIVE
To secure a challenging Drug Safety Physician position with a solid organization that will make a
significant contribution to the safety team; where I can use my education, knowledge, strong
clinical, therapeutic background, and experience to ensure the highest level of integrity, quality,
consistency, timeliness, accuracy and patient safety in clinical trials.
Professional Experience
March 2014- Current
Aristasis Inc.
Drug Safety Associate
• Processed SUSAR cases from various sources such as clinical trial, post-marketed,
literature, and solicited with an accuracy and consistency at various stages of the
system workflow
• Generated queries using ARGUS interface for clarification, resolving and forwarding to
next work flow and communicated to out-side sources to retrieve the required
information on the case report.
• Consistently used ARGUS features such as action items, contact log and work list for
communication and for the follow-up requests.
• Verification of accuracy and consistency
•
Determined and performed appropriate case follow-up, generating and requesting follow-
up letters.
• Assessed cases to distinguish those with particular complexities and/or specific issues,
and escalated to the respective team or an individual.
• Reviewed, ranked, verified, process and document: event terms; case classifications
(validity, seriousness, and expectedness/listedness/labelledness); special scenarios;
product complaint information; report ability with due date; and accuracy and
consistency. Based on assessment of cases, process accordingly.
• Generated aggregate and periodic reports such as IND/NDA, PSUR (Periodic Safety
Update Report)/CTPR, ensuring adherence to regulatory compliance timelines.
• Liaised, coordinated and communicated with key partners, including Pharmaceutical
Country Organizations, Clinical Development, License
Partners, and other stakeholders
regarding safety data collection and the Clinical data reconciliation.
• Developed and expertise on portfolio of company products within a therapeutic area with
respect to the data entry conventions; and search functions in the Argus safety database.
• Created and maintained integrated PV document for the various departments within and
with the relevant third parties, CROs and other business partners.
• Coordinated the authoring, reviewing, and publishing activities for regulatory report.
Received, documented and processed adverse event (AE) reports from clinical trials and
post-marketing in accordance with company Standard Operating Procedures (SOPs)
• Performed initial book-in and assessment of incoming reports from various sources such
as structured and unstructured
• Collected, documents, and processed adverse event (AE) reports from clinical trials and
post-marketing sources adhering to Standard Operating Procedures.
• Performed case Prioritization/Triaging based on seriousness of adverse events in
accordance with SOP guidelines
• Prepared clinical narrative summaries for ‘Adverse Event’.
• Case processing and FDA reporting of Medical devise.
• Performed medical coding using MedDRA and WHO-Drug dictionaries and composes
case narratives.
• Learn and perform Quality control review of prepared case and reports.
• Perform SAEs Reconciliation.
• Generated queries using ARGUS interface for clarification, resolving and forwarding to
next work flow
• Tabulated and formatted AE’s with Medwatch form for FDA regulatory reporting
• Resolution of queries of pending case.
• Perform exercised and get hands on experience of CIOMS line listing, Signal detection,
drug labeling edit check, PSUR reporting and case follow in SUSAR categories or not and
need to notified FDA or not.
• Performed necessary follow-up for missing, discrepant or additional information from
source documents
• Performed preparation of expedited and non-expedited reports to regulatory authorities
to ensure compliance with regulatory and within company time frame
• Participated in preparation of Periodic and aggregate safety reports
• Collaborated and coordinated with Data Management personnel to ensure that key data
fields are reconciled and assisted in resolving discrepancies
• Reviewed and modified aggregate reports and risk management documents to ensure
compliance with internal SOPs and external requirements/regulations
Jan 2014-Feb 2014
Ghosh Pediatrics
• Performed history taking, physical exams, and treated patients with various medical
conditions.
• Taught preventive medicine and new parents the basics of child care and nutrition.
• Vaccinated patients.
• Wrote SOAP notes and used the Electronic Health Record System efficiently and
effectively.
2007
Lakes Region Primary Care Center
• Shadowed Dr. Tina Piraino as a Medical Student.
• Conducted presentations on the prevention and treatment of various diseases and
medical ailments.
CPR certified from Maine Medical Center
Volunteer Tutor for Anatomy, Biochemistry and Pharmacology at St. Matthew’s University
2005
Research assistant at The University of Illinois at Chicago.
• Responsibilities included performing PCR amplification and Southern Blot of N.
Heterodon and N. heterolepis fish.
• The goal of this study was to determine if lake populations of these fishes can result in
genetically viable stocks if they are translocated from their native habitat to a manmade
environment
2003-2004
St. Alexis Medical Center
Volunteer at Day Surgery Waiting Room
Education
Drug Safety Associate 2014-Current
From Aristasis, New Jersey
Drug Safety Program 2014
From Clinical Research Academy of America (CRAA)
100 Menlo Park Drive, Edison, NJ 08837
MD 2008-2013
From University of Sint Eustatius School of Medicine, Bonaire, St. Eustatius
MD 2005-2008
From St. Matthews University School of Medicine, Grand Cayman Islands
MBA 2008-Present
From Davenport University
Concentration in Health Care Management
MHSA 2006-2007
From Saint Joseph’s College, Standish Maine
BS 2001-2005
From University of Illinois at Chicago
Major: Bachelor in Biological Sciences
Employment Eligibility Status: US Citizen
SUMMARY OF QUALIFICATIONS
• Physician with an expertise on industry principals of Drug Safety, Drug Development,
Pharmacology, Pharmaco-epidemiology and Global Reporting regulations.
• Comprehensive knowledge of drug safety and pharmacovigilance principles and regulations
• Extensive knowledge of drug development process and procedures
• Knowledge of ICH-GCP, FDA and EMA guidelines
• Knowledge of scientific terms and medical terminology
• Knowledge of Oracle ARGUS database
• Comprehensive knowledge of Clinical Trials (Phase I- IV)
• In-depth knowledge of MedDRA and WHO-drug coding
• Proficient in data entry and drug safety database
• Excellent written and verbal communication skills
• Proven interpersonal & organizational skills and analytical thinking
• Ability to analyze large data sets
• Self-motivated, effective communicator and a team player having ability to meet the team
goals in a matrix environment.
• Organized, hard- working and dedicated with good moral character.
• MRE, Triaging, Case processing and Data entry.
• A team player, quick learner who can formulate independent decisions.
• Strong ability to work in a dynamic and highly demanding environment.
• Proven interpersonal & Organizational skills and analytical thinking.
• Good computer skill like a MS word, excel and esp. ARGUS.
Contact this candidate