Dr. Papia Chandra has over 2 years of experience as a Medical Data Reviewer and Dental Surgeon. She has worked on clinical trials in areas such as diabetes, Alzheimer's disease, infertility, and oncology. Her skills include clinical research methodology, data management, pharmacovigilance, and medical coding.

1. DR. PAPIA CHANDRA
Address: Nag Residency #14, Anandnagar, 1st Block, 1st main, 2nd ‘B’cross,
RT Nagar Post Bangalore- 560032 Mobile: +91-9686070201, +91-9620024575
Date of Birth: 01/01/1986 E-Mail:drpapiachandra@gmail.comExp: 2.11 yrs
Objective:
To work in a challenging atmosphere that provides ample opportunity for learning and growth
and to carve a niche in whatever I undertake and to promote research activities with institution.
Summary:
I have over 2 years and 11 months of experience as Medical Data Reviewer in Clinical Data
Management, working in multiple therapeutic areas like Antidiabetic,Alzheimer’s disease,
Female infertility and Major Depressive Disorder and Oncology; accomplishments include: 
 Definition and terms used in clinical research and clinical trial and Pharmacovigilance.
 Overall knowledge of clinical Data Management and its process, Edit Checks, UAT, SAE
Reconciliation, Validation, Query Management, Discrepancy Management.
 CTMS and CDMS, Audit and Inspection, ICF and CRF.
 Coding and coded terms used in clinical research.
 ICH-GCP guidelines, Schedule Y, 21CFR part 11, ICMRguidelines.
 FDA, CDSCO,DCGI, EMEA.
 IND &NDA.
 History of Pharmacovigilance and Clinical Research.Well versed with pharmacovigilance in
clinical research, Benefit Risk assessment in Pharmacovigilance, Methods of
Pharmacovigilance, and Signal detection.
 Adverse Drug Reaction, classification and mechanism interaction, Adverse Event Case
processing, Serious Adverse Event Reporting and the timelines.
 PSUR, DSUR, ICSR,Aggregate Reporting,Causality Assessment, SUSAR, Unexpected
Adverse Reaction.
 Dictionaries used in clinical research and clinical trial (Medra, WHODD,WHOART,
COSTART).
Experience Profile:
 Worked as a Medical Data Reviewer in Clinical Data Management for Quintiles
Technologies (India) Private Ltd, Bangalore from June 2014 to May 2016.
 Worked as a Dental Surgeon for M N Advanced Dental Clinic,Bangalore from September
2012 to November 2013.

2. Formal Educational History:
Last Date
Attended
Institution Name,
Country
Education
Level/Degree
Area of Study Completion
Status
20/6/2014 ICRI PGDCR Clinical Research Completed
14/8/2013 Rajiv Gandhi
College Of Dental
Sciences and
Hospital
(Bangalore)
BDS(Bachelor in
Dental Surgery)
RGUHS Completed
Skill Set:
Training GCP certified
Operating System Windows 9x/2k/XP
Data Base Knowledge Inform, Rave database and Spot fire visualization
Previous Work Experience:
Organization:
Quintiles Technologies (India) Private Limited
Role: Medical Data Reviewer
Responsibilities Handled:
 Identifies any anomalies in patient reported data that require further investigation with the
clinical site to determine overall accuracy.
 Reviews all inclusion and exclusion criteria to ensure each patient meets minimum level of
acceptance into the clinical trial.
 Reviews investigation product dosing records to determine adherence to protocol and
identify possible inaccurate / missed dosages.
 Reviews all reported Adverse Events (AEs) , Concomitant Medication and medical history
information to ensure all supporting information is expected and/or implausible data is
verified and adherence to protocol expectations and its impact on other patient
reported/observed information (e.g., laboratory results, AEs, etc.).

3.  Ensures end-of-treatment (EOT) and end-of-study (EOS)information is correctly
documented to determine primary reason for the patient ending.
 Treatment or ending participation in the clinical trial.
 Reviews all laboratory results to ensure completeness of information and adherence to
protocol schedule of events and determine if reported laboratory values represent a
potential safety condition not reported in the AE information for the patient.
 Reviews any other information as necessary to determine overall readiness of the patient
information for next level review.
 Interacts with other Medical review staff to verify information and/or triage new data
issues or prior identified action items.
 Reviewing any other information as necessary to determine overall readiness of the patient
information for next level review.
 Reviewing all supplied Line Listings to determine data accuracy across patients within a
specified group of data points.
 Reviewing status information and data flow reports and take appropriate actions.
 Interacting with other Medical review staff to verify/clarify information and/or triage new
data issues or prior identified action items
 Updating the study related tracker
 Leading the team for appropriate handling of trial
 Attending Kick-Off meetings, weekly team meetings, and client meetings
Organization:
M N Advanced Dental Clinic
Role: Dental Surgeon
Responsibilities Handled:
 To perform Root canal Treatment,Restorations, and oral hygiene instructions.
 To attend cases in outpatient department.