Pradeep Kumar Vasudevan
Bengaluru
Summary
Dynamic Senior Medical Reviewer with extensive experience, excelling in clinical research and safety management. Proven track record in risk-based quality management and strategic planning, enhancing patient safety through data analysis and effective communication. Spearheaded digital transformation initiatives, integrating AI solutions to optimize trial processes and ensure regulatory compliance.
Overview
15
15
years of professional experience
1
1
Certification
Work History
Senior Medical Reviewer – Centralized Monitoring Unit – Development
Novo Nordisk
Bengaluru
06.2019 - Current
- Led medical review for cardiovascular and emerging therapy areas, offering strategic input during trial execution.
- Served as primary medical monitoring expert for early and late-phase trials.
- Streamlined Phase 1 monitoring process in compliance with risk-based quality management (RBQM).
- Review of Protocol, Information brochure during development stage, Prepared risk-based monitoring plans, Trial Operations plan, Data Management plan, Monitoring guidance documents and provide medical input during trial planning.
- Supported clinical operations and CRA by addressing site queries and preparing Q&A newsletters
- Support trials on safety data and ATC coding, optimizing MedDRA usage for trial specifications.
- Enhanced patient safety through thorough reviews and identification of safety trends across multiple projects from ATTR CM, HF, CV Outcome, Obesity, Diabetes, MASH, and Devices projects.
- Chaired medical monitoring meetings to oversee safety, clinical case findings, protocol deviations, and risk mitigation.
- Mentored colleagues, streamlined processes, and ensured inspection readiness during audits for trials.
- Spearheaded process transformation and digitalization initiatives, including EDC Superuser, EDC setup, and Integrated Quality Risk Management platform development.
- Integrated AI/ML-driven solutions into clinical trials for data analysis and risk assessment.
Medical Data Reviewer
IQVIA
Bengaluru
09.2018 - 05.2019
- Conducted aggregate data review, preparing cumulative summary reports with data visualization and MedDRA analysis
- Performed medical review of trial-related Adverse Events (AEs), including narrative content, coding, expectedness, seriousness, and causality.
- Led signal detection and validation activities for marketed products. Medical review of PSUR, DSUR and RMP’s.
- Reviewed Investigator Brochures (IBs) for safety updates based on emerging trends.
- Acted as Clinical Data Scientist, identifying protocol deviations and issuing queries in Electronic Database.
- Ensured audit readiness for regulatory submissions.
Clinical Pharmacologist - Head Department of Clinical Pharmacology, Basic Medical Scientist, Institutional Ethics Committee
Apollo Hospitals
Chennai
10.2014 - 08.2018
- Led Pharmacology department, ensuring medication safety and formulary management.
- Served as Institutional Ethics Committee member, reviewing clinical trial protocols for ethical compliance.
- Ensured clinical research site compliance with GCP standards.
- Coordinated Pharmacovigilance Program of India within Apollo Hospitals, Chennai region.
- Acted as Internal Quality Auditor for JCIA and NABH standards
Medical Officer – Emergency Care Physician
NIMS Hospital
Thiruvananthapuram
05.2010 - 05.2011
- Managed cardiac emergencies, providing critical patient care, including intubation and ventilator management.
Education
Post Graduate Program - Artificial Intelligence and Machine Learning
Texas McCombs, Great Lakes
01-2023
M.D. - Pharmacology
Raja Muthiah Medical College & Hospital, Annamalai University
Tamilnadu04-2014
Advanced Post Graduate Diploma - Clinical Research & Pharmacovigilance
Academy of Clinical Research & Healthcare Training And Management
01-2012
MBBS -
The Tamil Nadu Dr. MGR Medical University
Tamilnadu01-2009
Post Graduate Diploma - Health Science in Diabetology
Annamalai University
Skills
- Clinical Research & Safety Management
- Risk-Based Quality Management & Data Analysis
- Strategic Planning
- Patient safety
- Adverse Event Reporting & Site Monitoring
- Regulatory Compliance & Protocol Adherence
- AI & Machine Learning in Clinical Trials
- Effective Communication & Team Collaboration
Certification
Advanced Good Clinical Practice (AGCPC) – CCRPS - Good Clinical Practice (ICH-GCP), Certified–2025 Human Subjects Research–CITI Program
Languages
English, Malayalam, Hindi, Tamil
Languages
English
First Language
Timeline
Senior Medical Reviewer – Centralized Monitoring Unit – Development
Novo Nordisk
06.2019 - Current
Medical Data Reviewer
IQVIA
09.2018 - 05.2019
Clinical Pharmacologist - Head Department of Clinical Pharmacology, Basic Medical Scientist, Institutional Ethics Committee
Apollo Hospitals
10.2014 - 08.2018
Medical Officer – Emergency Care Physician
NIMS Hospital
05.2010 - 05.2011
Post Graduate Program - Artificial Intelligence and Machine Learning
Texas McCombs, Great Lakes
M.D. - Pharmacology
Raja Muthiah Medical College & Hospital, Annamalai University
Advanced Post Graduate Diploma - Clinical Research & Pharmacovigilance
Academy of Clinical Research & Healthcare Training And Management
MBBS -
The Tamil Nadu Dr. MGR Medical University
Post Graduate Diploma - Health Science in Diabetology
Annamalai University
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