Microsoft office 365/Microsoft Power BI
Dr. Vijay Kumar
Assistant Manager, Saftey Surveillance Scientist/Medical Reviewer
Bangalore,Karnataka
Summary
Enthusiastic medical Professional, having overall 5.5 years of experience in clinical practice and clinical research industry, eager to contribute to team success through hard work, attention to detail and excellent organizational skills. Clear understanding of Patient Safety Surveillance, Risk based monitoring/centralized monitoring and trained in Health care Data Analytics.I align myself with high-quality industry level clinical research and incorporate innovative ideas to improve workflow and bring business to the organization.
Overview
6
6
Certifications
8
8
years of post-secondary education
4
4
years of professional experience
Work History
Assistant Manager, SS Process Expert.Life Sciences
Tata Consultancy Services
Mumbai, Maharastra
12.2020 - Current
- Routine safety surveillance, signal identification, Primary evaluation and detailed trend evaluation of safety signal from the review of safety data.
- Processing of ICSR and its medical review, creation of periodic safety report, signal detection and management activities
- Review eligibility criteria, IP product dosing, Reported Adverse Events, Medication, and medical history information to ensure all supporting information is expected and/or implausible data is verified and adherence to protocol
- Maintain the Productivity of the study and Quality of the dataset. Review the all reported Adverse Events (AEs), Concomitant Medication and medical history, Lab reports related to Drug molecule/ Medical Device. Also, literature reviews for Post Market Support activities.
Senior Medical Data Reviewer
IQVIA RDS (INDIA)
Bangalore, Karnataka
07.2018 - 11.2020
- Team Lead Role: Point of Contact
- Responsible for project delivery of clinical development phase EDC studies. Review and approval of study documents during Study Start Up phase.
- Creating required Data Elements and Edit Checks. Providing requirement and assisting the SPOTFIRE programmers to create visualizations as per study requirement , including UAT testing.
- Highly involved in Protocol development, eCRF designing and instructions and related amendments.
- Conduct in-stream data trend analysis in support of data quality and integrity (includes protocol compliance and medical review of subject data.
- Ensure quality control procedures, critical milestones for the study are achieved within stipulated timelines in accordance with ICH-GCP guidelines.
Clinical Observer Ship
Tata Medical Center
Kolkata, West Bengal
05.2013 - 05.2014
- Clinical observer in the Head & Neck oncology
- Assisted in surgeries and post surgical management of patients
Lecturer
Department of Prosthodontics, Crown & Bridge, Manipal College of Dental Sciences, Manipal, India
Manipal, Karnataka
09.2012 - 04.2013
- Evaluated and revised lesson plans and course content to achieve student-centered learning.
- Communicated one-on-one with patients during consultative appointments to explain treatment plan and educate on upcoming procedures.
- Created individualized treatment plans to maintain or restore oral health of patients.
Education
Master of Dental Surgery (MDS) - Public Health
Government Dental College & Research Institute
Bangalore 06.2015 - 06.2018
Bachelor of Dental Surgery (BDS) - Dental Subjects
Manipal College of Dental Sciences
Manipal University 08.2007 - 08.2012
Skills
Medical/Clinical Operations
undefinedAdditional Information
Date of Birth : 15th Feb
Marital status : Single
Nationality : Indian
Languages : English: Business Level
Marathi: Fluent
Hindi: Fluent
Kannada: Intermediate
Software
EDC Medidata Rave/TIBCO Spotfire
SPSS/R
NGSMS/Supphire
Certification
Lean Six Sigma Green Belt,
Analytical Domain Work Experience
Experienced on the Health economic analysis models like cost effective, cost benefit and cost utility analysis for the drug development in the USA healthcare market.
• Created the “Productivity and Quality dashboard” and monthly generating reports on Microsoft Power BI Tool.
• Providing the Medical, Visualization and statistical input on the special project on the ‘Fraud Analysis: Possible Misconduct, 2020’ under AMGEN portfolio.
• Created and implemented the Predictive analytical model on the prediction of “Potential PEP” in the Cardiovascular Trial.
• Provided the Medical Interpretation during Sentiment Analysis & Text Summarization on ‘Product Labelling and New Drug Submission, FDA, 2019.
• Creating the “Central Statistical Monitoring Checks” in “Data Management Plan” and assisting the AMGEN Statistical team for signal detection.
Accomplishments
Bronze Award for winning ‘Innovator award, 2019’ for the best poster in innovation category among CROs under AMGEN.
• Awarded and part of team “Dr Syndrome” came as 1st runner-up in IQVIA HACKATHON-2019.
• Honored for developing ‘Analytical Business Model’ as “Predicting Possible Missing Endpoints Related to Cardiovascular Outcome Trials featured in India Innovation Council -Newsletter 2019 Issue 4
• Shout Out! Award for developing “Predictive Analytical Model” in Cardiovascular Trial
• Bravo! Award for working in the Natural Language Processing (NLP) process and Sentimental analysis for Product Labelling, FDA.
• Bronze Award for the initial analytical framework on “Fraud Analytics” in Nov 2019.
• Best Table talk presentation in affordable dental care at 11th PG Convention Sri Balaji Vidyapeeth Pilliyarkuppam, Puducherry - 607402, 2017
Timeline
Lean Six Sigma Green Belt,
01-2021
Assistant Manager, SS Process Expert.Life Sciences
Tata Consultancy Services
12.2020 - Current
Agile & Scrum- Project Management, E1
01-2020
Senior Medical Data Reviewer
IQVIA RDS (INDIA)
07.2018 - 11.2020
Master of Dental Surgery (MDS) - Public Health
Government Dental College & Research Institute
06.2015 - 06.2018
Clinical Observer Ship
Tata Medical Center
05.2013 - 05.2014
Lecturer
Department of Prosthodontics, Crown & Bridge, Manipal College of Dental Sciences, Manipal, India
09.2012 - 04.2013
Bachelor of Dental Surgery (BDS) - Dental Subjects
Manipal College of Dental Sciences
08.2007 - 08.2012
Similar Profiles
Vrunda ChindhadeVrunda Chindhade
HR Manager at Tata Consultancy Services, TCS, Tata Consultancy Services LimitedHR Manager at Tata Consultancy Services, TCS, Tata Consultancy Services Limited
Sreya BasuSreya Basu
Procare Analyst at Tata Steel(Tata Consultancy Services)Procare Analyst at Tata Steel(Tata Consultancy Services)
Arun VArun V
Program Manager at Tata consultancy services | Financial Ombudsman ServicesProgram Manager at Tata consultancy services | Financial Ombudsman Services