Dr.B.SUJIN KUMAR BALAKRISHNAN
Medical Doctor
Marthandam
Summary
Experienced medical doctor with over nine years of experience in medical field. Over 4 Years of experience as safety physician (medical reviewer) Excellent reputation for resolving problems, improving customer satisfaction, and driving overall operational improvements.
1.5 Years of experience in clinical research. Medical review of Coding (MedDRA, WHO drug) for the appropriateness. Ongoing safety review of individual patient laboratory reports generated by central laboratories.
3.6 years of pharmaceutical industry experience in drug safety, safety database including ARGUS, Aris-g.
Overview
9
9
years of professional experience
1
1
Language
Work History
Medical Officer (Associate Medical Manager)
Fortrea Inc
05.2023 - Current
- Undertake primary medical review of cases, including medical assessment of the case for seriousness, listed/labeling, causality, adverse event coding and narrative review.
- Update and document daily case data, case-feedback in appropriate trackers/tools to facilitate tracking and workflow management
- Assume complete responsibility for all assigned deliverables in line with expected quality, compliance and productivity SLAs and KPIs.
- Provide training and guidance to the case processing team on medical aspects of case processing
- Performs secondary medical review (QC role) and retrospective review of cases reviewed (QA role), as required for measuring quality of deliverables, identifying error trends, training needs and areas of improvement
- Creates, maintains and assumes accountability for a culture of high customer service
Medical Officer (PV Physician)
Tata consultancy services limited
11.2021 - 3 2023
- Medical review of Individual Case Safety Reports (ICSRs) from all sources in compliance with applicable regulations, procedures and in accordance with client specific requirements and timelines.
- Maintain timely submission of ICSR and SUSAR reports.
- Determine proper MedDRA code, evaluate
labelling, review narrative. - Performed duties in accordance with all applicable standards, policies and regulatory guidelines to
promote safe working environment. - Provide medical safety input as appropriate to Case Processing teams regarding expectedness/listedness/labeledness, causality.
Medical Officer (Safety Physician)
ICON clinical research organization
12.2020 - 10.2021
- ICSR case review
- Literature case Review
- Triage of cases
- Identify severity and relatedness throughout products.
- Determine proper MedDRA code, evaluate labelling, review narrative.
- Verify proper selection of adverse events from source documents
Medical Officer (Clinical Research Physician)
ICON clinical research organisation
07.2019 - 12.2020
- Medical support to our Project Teams in Medical Safety, in order to ensure that projects of all phases (I-IV) are conducted according to the highest ethical principles and medical standards, in accordance with good pharmacovigilance practices and in compliance with applicable legal and regulatory standards.
• Serve as medical team leader on assigned projects
• Ensure provision of all contracted activities and identification of out of scope activities on projects assigned
• Provide medical monitoring support for clinical teams.
• Provide in-depth knowledge to physicians and site associated staffs by conducting kick-off meetings, product related snapshots, presentations and other
• Provide project management as contracted
• Self-prepared and/or assisting physicians in identifying and development of project training materials
• Ensure that project training is completed and documented across all staff assigned to the Medical Affairs team.
• Assist MM team in initiation and coordination of change order activities
• Assist MM team in addressing costs (working knowledge of medical costing tool) in support of RFPs and reviewing associated text
Medical Officer (Telemedicine Co-ordinator)
Teamlease PVT limited
06.2017 - 03.2019
- Quickly learned new skills and applied them to daily tasks, improving efficiency and productivity.
- Served customers in a friendly, efficient manner following outlined steps of service.
- Handled day-to-day running of oncology project, ensuring high levels of productivity and progression.
- Carried out day-day-day duties accurately and efficiently.
- Worked closely with cancer patients to maintain optimum levels of communication to effectively and efficiently complete projects.
- Developed and maintained courteous and effective working relationships.
Medical Officer
Anithara Hospital
09.2015 - 05.2017
- Consulted with surgeons to discuss patient needs, risks and protective strategies to prevent degeneration of conditions.
- Identified serious conditions and emergency situations and immediately referred to hospital for prompt care.
- Wrote medical prescriptions, detailing side effects and possible adverse reactions to keep patients informed and alert of potential issues.
- Evaluated patient histories, complaints and current symptoms to understand conditions and begin diagnostic processes.
Education
M.B.B.S - Medicine
Rajah Muthiah Medical College & Hospital
Chidambaram 09.2008 - 2015.08
Skills
Emergency medical care
Teamwork
Patient Relations
Patient Care
Patient collaboration
DOB
04 JAN 1991
Professional Membership
Tamilnadu Medical Council Registration.
Hobbies
Travelling
Timeline
Medical Officer (Associate Medical Manager)
Fortrea Inc
05.2023 - Current
Medical Officer (PV Physician)
Tata consultancy services limited
11.2021 - 3 2023
Medical Officer (Safety Physician)
ICON clinical research organization
12.2020 - 10.2021
Medical Officer (Clinical Research Physician)
ICON clinical research organisation
07.2019 - 12.2020
Medical Officer (Telemedicine Co-ordinator)
Teamlease PVT limited
06.2017 - 03.2019
Medical Officer
Anithara Hospital
09.2015 - 05.2017
M.B.B.S - Medicine
Rajah Muthiah Medical College & Hospital
09.2008 - 2015.08
Similar Profiles
Alice WilsonAlice Wilson
Senior Line Manager at Fortrea IncSenior Line Manager at Fortrea Inc
Maxwell MascarenhasMaxwell Mascarenhas
Assistant II PSS at Fortrea IncAssistant II PSS at Fortrea Inc
Małgorzata KowalskaMałgorzata Kowalska
Project Coordinator I at Fortrea (Formerly LabcorpProject Coordinator I at Fortrea (Formerly Labcorp