SOWNDARIYA LAKSHMI
SENIOR MEDICAL DATA REVIEW PHYSICIAN
CHENNAI,TN
Summary
Dedicated and focused Senior Clinical Research Physician with extensive experience in phase 1-4 trials. Proficient in FDA, GCP and ICH guidelines. Expertise in clinical trial design, medical monitoring and safety management. Highly organized with excellent planning, problem-solving, and attention to detail. Experienced in providing both clinical and administrative support, including primary healthcare and emergency response. Ability to collaborate with sponsors and investigators to deliver high quality research.
Clinical research professional with robust background in conducting and managing clinical trials. Known for delivering meticulous research and contributing to development of new therapies. Highly reliable team player with strong focus on collaboration and adaptability to meet evolving project demands. Proficient in patient safety, data management, and regulatory compliance.
Overview
4
4
Languages
1
1
Certification
12
12
years of professional experience
Work History
Senior Medical Data Review Physician
ICON plc Clinical Research Organisation
06.2024 - Current
- Coordinate and conduct comprehensive medical data review activities across assigned Phase I–IV clinical trials, ensuring medical accuracy, consistency, completeness and compliance with study protocols, project plans and applicable regulatory requirements.
- Perform holistic patient-level and aggregate medical data reviews, applying clinical judgment to identify medical inconsistencies, missing information, potential safety concerns and protocol deviations.
- Provide medical oversight and therapeutic expertise in the planning, execution and management of medical review activities across assigned clinical projects.
- Review and interpret clinical data, including adverse events, serious adverse events (SAEs), laboratory findings, medical history, concomitant medications and clinical efficacy parameters.
- Perform medical coding reviews using MedDRA and WHO Drug Dictionary, ensuring accuracy, consistency, clinical appropriateness and completeness of coded terms.
- Conduct oncology-specific medical data reviews, including patient profile assessments, tumour response evaluations using RECIST 1.1 and LUGANO criteria, and SAE reconciliation.
- Identify, assess and facilitate resolution of medical queries in collaboration with Medical Directors, clinical data management, safety teams and other cross-functional stakeholders.
- Review and contribute to medical monitoring plans, clinical study documentation, medical review reports and periodic project deliverables.
- Ensure quality and timely delivery of medical review activities in accordance with project requirements, SOPs, ICH-GCP guidelines and applicable regulatory standards.
- Participate in internal and client meetings, providing medical insights, discussing review findings and supporting resolution of clinical data-related issues.
- Provide medical guidance and training to clinical research teams on medical data review, safety assessment and therapeutic-specific requirements.
Clinical Research Physician
02.2020 - 06.2024
Clinical Investigator
Azidus Laboratories Clinical Research Organisation
04.2018 - 01.2020
Junior Resident
ANIMS HOSPITAL
11.2015 - 06.2016
Duty Medical Officer
GLB Stoke speciality Hospital
06.2015 - 11.2015
Duty Medical Hospital
Vijaya Hospital
01.2015 - 06.2015
Education
Certificate course - Pharmacovigilance Aggregate Reporting
Udemy
03-2026
Diploma - clinical research and pharmacovigilance
Carrer in Pharma
Bangalore07-2024
Diploma - Diabetology
Apollo Medvarsity
Chennai10-2015
MBBS - undefined
Mahatma Gandhi College and Research Institute
Pondicherry01-2014
Higher Secondary - undefined
Alpha Matriculation Higher Secondary school
Pondicherry01-2008
Skills
- Clinical study monitoring
- Medical consultation expertise
- Medical data review
- Contract management oversight
- Cross-functional collaboration
- Well versed in MS word, Excel and PowerPoint
- Expert in using RAVE, Veeva Vault, Trial kit, clin info
Certification
BLS and ACLS certified from AHA
Other competencies as Junior resident
- Collaborated with physicians, specialists, and healthcare providers to deliver comprehensive care for complex cases.
- Managed patient admissions, triage, and monitored conditions, including interpreting EKG readings.
- Provided patient and family education on diagnoses, treatment options, disease management, and lifestyle changes.
- Delivered emergency treatments and implemented therapeutic regimens to prevent recurrence of conditions.
Declaration
I hereby declare that the entries in this form furnished herewith are true to the best of my knowledge and belief. DR. Sowndariya Lakshmi
Timeline
Senior Medical Data Review Physician
ICON plc Clinical Research Organisation
06.2024 - Current
Clinical Research Physician
02.2020 - 06.2024
Clinical Investigator
Azidus Laboratories Clinical Research Organisation
04.2018 - 01.2020
Junior Resident
ANIMS HOSPITAL
11.2015 - 06.2016
Duty Medical Officer
GLB Stoke speciality Hospital
06.2015 - 11.2015
Duty Medical Hospital
Vijaya Hospital
01.2015 - 06.2015
Higher Secondary - undefined
Alpha Matriculation Higher Secondary school
MBBS - undefined
Mahatma Gandhi College and Research Institute
Diploma - Diabetology
Apollo Medvarsity
Diploma - clinical research and pharmacovigilance
Carrer in Pharma
Certificate course - Pharmacovigilance Aggregate Reporting
Udemy