Dr. Mayurkumar Varmora
Mahuva
Summary
Astute Medical reviewer/Drug Safety Physician known for high productivity and efficient task completion. Possess specialized skills in pharmacovigilance, medical review, and adverse event
reporting. Excel at communication, critical thinking, and problem-solving to ensure patient safety and compliance with regulatory standards.
Overview
9
9
years of professional experience
Work History
Assistant Manager
Lambda
06.2025 - Current
- Responsible for medical review of ICSRs for accuracy, medical relevance, and overall consistency of information captured in the safety database against all the applicable supporting documents as per the client requirement.
- Evaluate adverse event report for seriousness, listedness/expectedness, corrects coding of the adverse event and ensures that all medically relevant information from the source documents is included, checks/corrects ranking of events, and provide causality assessment.
- Confirm and rectify coding of terms in other fields such as medical history, lab details or indications.
- Provide medical comment on the case.
- Ensure appropriate follow-up questions/questionnaires are sent out based on the case.
- Track inconsistencies on activities performed by data entry and QC reviewer and provide feedback to QC team as learnings activities as per client requirement and agreed standards.
Senior Medical Safety Physician/Assistant Manager
Wipro Pvt Ltd
09.2022 - 04.2025
- Perform Medical Review of Literature articles
- Assessing seriousness, causality, labelling, verifying the Meddra coding, narrative, ADR, SAE and providing medical assessment comment for the case
- Reviewing the published reports/biomedical literature to ascertain if they contain a case report of an adverse reaction and Non- individual case reports
- Applying regulatory and internal guidance to determine if the article meets the definition of a case report and Non- individual case report.
- Provide training and guidance to the scanners on inclusion criteria of case report and Non- individual case reports
- Work closely with the SMEs to ensure physician team has necessary training and skills per industry norms.
- Perform additional tasks/responsibilities as assigned delegated by the team lead/manage.
Senior Medical Safety Physician
Bioclinica Pvt Ltd
06.2021 - 08.2022
- Conduct review and assessment of individual case safety reports obtained from clinical trials, spontaneous and solicited reports
- Perform triage of cases and determine seriousness and relatedness across products as assigned
- Review and verify appropriate selection of adverse events from source documents, assign appropriate MedDRA code, assess labelling, review narrative
- Acquire and maintain current knowledge of product portfolio and safety profiles for products across therapeutic areas
- Escalate complex case issues on client product(s) to the medical review team of the client as appropriate
- Conduct assessment of litigation cases across products as assigned
- Review of PBRER (Periodic Benefit-Risk Evaluation Report) and PADER (Periodic Adverse Drug Experience Report) as and when required
- Identify and resolve case issues, coordinate with client therapeutic teams/site for specific products or functional groups
- Communicate and interact effectively within and across all client therapeutic teams, and within functional team management as appropriate
- Acquire and maintain knowledge of applicable Global Health Authority regulations
- Perform any other drug safety related activities as assigned
- A global provider of clinical trial management services and medical imaging solutions
Senior Medical Reviewer
Cognizant Technology Solutions
09.2019 - 05.2021
- Accurate and timely processing of drug safety database action items
- Execution of a high quality, accurate and timely medical assessment for the assigned cases and contribution to continuous improvement of PV system and process
- Verification and appropriate medical assessment and seriousness for adverse events
- Confirmation of the accuracy of MedDRA coding of reported adverse events, and concurrent diseases following clients global coding rules
- Closure of action items raised by clients end
Human Medical Assessor/ Medical Reviewer
Tata Consultancy Services
Mumbai
09.2018 - 09.2019
- Accurate and timely processing of drug safety database action items
- Execution of a high quality, accurate and timely medical assessment for human cases and contribution to continuous improvement of PV system and process
- Verification of global assessment and seriousness for human adverse events
- Confirmation of the accuracy of VedDRA/MedDRA coding of reported adverse events, and concurrent diseases following clients global coding rules
- Closure of action items raised by clients end
- Forwarding cases to Quality Check
- A leading global IT services, consulting, and business solutions organization
Physician Partner
Inventurus Knowledge Solutions
Mumbai
02.2017 - 09.2018
- To work with US physicians and apply clinical knowledge, to impact patient care
- Quality analysis
- Audio visual audits of scribed chart notes for the physicians of Massachusetts General physicians organization
- Work with a team to edit the data in Electronic Health Records that is audited by the physicians in US
- Manage a team of doctors and US physicians with appropriate client satisfaction
- Actively participated in KRA of the team
- Illness, review of systems, physical examination, plan details, etc
- Populate the summarized data in the electronic health record
- Familiar with EHR like Epic
- Trained new employees on EHR
- Company focused on healthcare solutions, working with US physicians to improve patient care
- Received training for CTP/TL role including process knowledge, client management, team management, interpersonal skill development
- Successfully onboarded client physician; taking the responsibility in absence of TL
- Managed U.S physician interactions including query solving regarding the scribed notes by emphasizing on the benefits to them
- Involved in onboarding new client physicians from MGH
Education
Bachelor of Medicine And Bachelor of Surgery - Medicine (MBBS)
Medical College of Qingdao University
Qingdao, China07-2015
Higher Secondary (HSC) -
Harivandana school of science
Rajkot01.2009
Secondary school -
Saint Thomas School
Mahuva01.2007
Skills
- Medical review
- ICSR Review
- Medical assessment comment
- Seriousness assessment
- Literature article review
- Meddra Coding
- ADR, SAE, AE assessment
- Spontaneous, Literature, CT case MR
- Labelling
- Narrative
- Author attribution
- RCA-CAPA guidance
- PBRER (Periodic Benefit-Risk Evaluation Report) and PADER (Periodic Adverse Drug Experience Report)
- Knowledge transfer sessions
- Basic computer skills and knowledge
- Knowledgeable in MS-Office
Personal Information
Date of Birth: 05/10/91
Languages
- Gujarati
- English
- Hindi (can read & write)
- Chinese (Can speak fluently)
Hobbies and Interests
- Listening to music.
- Interacting with people.
- Watching cricket.
- Reading books.
- Travelling.
- Foodie.
Personality Traits
- Loyal and disciplined towards duties.
- Extremely Hard Working & Career Oriented.
- Good knowledge of medical protocols and terminology.
- Ability to work in a Team efficiently.
- Excellent communication skills in written and verbal both.
- Controlling multiple projects at the same time.
- Always eager to learn new skills.
Languages
English
Proficient
C2
Chinese (Mandarin)
Intermediate
B1
Gujarati
Proficient
C2
Hindi
Advanced
C1
Timeline
Assistant Manager
Lambda
06.2025 - Current
Senior Medical Safety Physician/Assistant Manager
Wipro Pvt Ltd
09.2022 - 04.2025
Senior Medical Safety Physician
Bioclinica Pvt Ltd
06.2021 - 08.2022
Senior Medical Reviewer
Cognizant Technology Solutions
09.2019 - 05.2021
Human Medical Assessor/ Medical Reviewer
Tata Consultancy Services
09.2018 - 09.2019
Physician Partner
Inventurus Knowledge Solutions
02.2017 - 09.2018
Bachelor of Medicine And Bachelor of Surgery - Medicine (MBBS)
Medical College of Qingdao University
Higher Secondary (HSC) -
Harivandana school of science
Secondary school -
Saint Thomas School