Dr. Pavana Gopinath
Bangalore/Bengaluru
Summary
Dynamic medical professional with a proven track record in medical data review and oncology medical analysis, notably at IQVIA. Skilled in oral histopathology and diagnosis, leveraging medical writing and coding to enhance patient care and trial outcomes. Demonstrates meticulous attention to detail and a robust ability to translate complex medical data into actionable insights.
Overview
14
14
years of professional experience
1
1
Certification
Work History
Medical Data Reviewer
IQVIA
Bengaluru
02.2024 - Current
- Serve as a Subject-level Data reviewer (SLDR) and identify any anomalies in patient-reported data by performing Subject Level Data Review that require further investigation with the clinical site to determine overall accuracy.
- Review all inclusion and exclusion criteria to ensure each patient meets the minimum level of acceptance into the clinical trial.
- Review investigation product dosing records to determine adherence to protocol and identify possible inaccurate or missed dosages.
- Review 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.).
- Ensure end-of-treatment (EOT) and end-of-study (EOS) information is correctly documented to determine the primary reason for the patient ending treatment or ending participation in the clinical trial.
- Review 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.
- Review any other information as necessary to determine overall readiness of the patient information for next level review.
- Interaction with other medical review staff to verify information and/or triage new data issues or previously identified action items.
Medical Analyst- Oncology Data Abstraction
ConcertAl
Bengaluru
04.2023 - 07.2023
- Access electronic data systems for review of medical records and enter specific data into congruent electronic data systems.
- Review project-specific documents, as needed, to develop familiarity with project goals and with the Abstractor tasks in each project.
- Use other resources as needed to gain the knowledge required to perform Abstractor work on new projects.
- EDCS-EMOLHealth, TenorLumos, IBIS, SOLIS
- Oncology Therapeutic areas: Pancreas, Breast, Lung
Centralized Monitor
IQVIA
07.2017 - 11.2020
- Performed holistic review of case reports and identified anomalies in the reported medical data that require further investigation with the clinical site and to determine the overall accuracy
- Review of all criteria to ensure each patient meets minimum level of acceptance into the clinical trial, ensure accurate medical history information, adverse events, SAE reconciliation, laboratory results, IP dosing and end of study procedures
- Served as back-upPOC
- Therapeutic areas-Cardiovascular:Hypertriglyceridemia, Phase-3, Nephrology: Renal impairment, Phase 2 and Neurology: Alzheimer's Disease, Phase 3
Post Graduate Resident
GDCRI
06.2013 - 08.2016
- Diagnosed oral and maxillofacial lesions by histopathology and cytopathology
- Referred patients immediately to respective departments for prompt care
- Evaluated patient history, complaints and current symptoms
- Thoroughly examined medical history to use in assessing health conditions
- Worked on immunohistochemistry, tissue micro-array and other histopathological diagnostic aids
General Dentist
Prabha Dental Clinic
10.2010 - 10.2011
- Provided emergency dental treatments prioritizing both functionality and aesthetics
- Performed restorations, scaling, root canal treatment, extractions and assisted during oral surgeries
Education
MDS - Oral and Maxillofacial Pathology
Government Dental College And Research Institute
01.2016
BDS - Dentistry
Rajarajeswari dental college and hospital
01.2010
Class XII -
Bishop Cotton Girls' School
Bengaluru01.2005
Skills
- Oral Histopathology And Diagnosis
- Medical Data Review
- Oncology- Medical Analysis
- Medical Writing
- Medical Coding
Certification
- Advanced Certification In Forensic Science And Forensic Odontology- International Forensic Sciences
- Medical Writing-Karnataka Clinical Research Institute.
- Fundamentals Of GCP Training
- Principles-GCP Training
- IQVIA Expert GCP Exam For Managers And Staffl Nteracting With Investigational Sites
- Currently Pursuing Medical Coding Course- Henry Harvin
- Completed certification in Medical Writing (Karnataka clinical research institute)
Accomplishments
- 6 Papers published in peer-reviewed indexed journals
- Won the IAOMP Quiz held at XVNational PG convention, Vadodara, 2015
- Topper in various subjects-RRC&H.2005-2010
- Batch Representative, Rajarajeswari Dental college, Bengaluru- 2005-2010 - Organized annual cultural and sports activities for over 500 students.
- Apart of organizing committee of CDE program (Pathocognizance-1&2) at GDCRI, Bengaluru, 2014 & 2015.
- Appreciation Award - Cardiovascular: Hypertriglyceridemia, Phase 3 study IDBL activities, 2018
- AppreciationAward-Nephrology: Renal impairment Phase2 Study DB Lock activities, 2019
Publications
- 1. Central giant cell granuloma in a 4-year-old female child. J Indian SocPedodPrev Dent. 2015 OctDec;33(4):337-40.
- 2. A 10-year retrospective study on epidemiology and clinicopathological presentation of solid and unicystic variants of ameloblastoma. J Oral MaxillofacPathol. 2014 Nov; 18(Suppl 2): S36???S111
- 3. Economic methods used in fabrication of tissue microarray: A pilot study. J Oral MaxillofacPathol 2016; 20:86-90
- 4. Glandular Odontogenic Cyst: A Case Report. AOSR 2014;4(2);162-167.
- 5. Snail expression in oral squamous cell carcinoma. American Journal of Oral Medicine and Radiology. 2016; 3(2): 99-103.
- 6. High grade B cell Lymphoma- A Case Report. International journal of advances in pediatric dentistry.
Timeline
Medical Data Reviewer
IQVIA
02.2024 - Current
Medical Analyst- Oncology Data Abstraction
ConcertAl
04.2023 - 07.2023
Centralized Monitor
IQVIA
07.2017 - 11.2020
Post Graduate Resident
GDCRI
06.2013 - 08.2016
General Dentist
Prabha Dental Clinic
10.2010 - 10.2011
MDS - Oral and Maxillofacial Pathology
Government Dental College And Research Institute
BDS - Dentistry
Rajarajeswari dental college and hospital
Class XII -
Bishop Cotton Girls' School
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