SAIRAJ SUTAR
Kalyan
Summary
Demonstrates strong analytical, communication, and teamwork skills, with proven ability to quickly adapt to new environments. Eager to contribute to team success and further develop professional skills. Brings positive attitude and commitment to continuous learning and growth.
Overview
7
7
years of professional experience
1
1
Certification
Work History
Medical Safety Scientist
Qinecsa Solutions
12.2020 - Current
- Managed a team of medical reviewers handling 10,000+ adverse event reports per year
- Function as a management level liaison between Client and Qinecsa Project team
- Provide guidance for medical reviewers
- Train and mentor new team members as per the requirements of the project
- Coordinate and manage administrative project issues
- Oversee mentor and guide the activities of the Drug Safety and Senior Drug Safety Associates
- Function as guide coach and counselor for team
- Following up with sites regarding outstanding queries and reconciliation of discrepancies
- Contribute to signal detection activities by analysis of cases in safety database literature review for AESI and close monitoring events
- Support in creating signal assessment report for data quality causality and signal management
- Contribute to development of Risk management plan for 3 oncology products
- Conduct review and assessment of individual case safety reports obtained from clinical trials spontaneous literature and solicited reports in oncology therapeutic area
- Perform medical triage of cases to determine seriousness and relatedness
- Review and verify appropriate selection of adverse events from source documents assign appropriate MedDRA code assess labeling review narrative
Medical Reviewer
Tata Consultancy Services
10.2019 - 11.2020
- Conducted a literature review of approximately 25 cases each day consistently achieving 100% quality in critical fields
- Download abstracts and literatures for individual cases from online database with the use of search strategy/keywords
- Review abstracts and literatures for individual cases determine their validity
- Perform triage of cases and determine seriousness and relatedness across products as assigned
- Final medical review and locking of literature cases
- Complete individual cases within time limit and meet the SLA for data entry and case analysis activities as per SOP
- Train drug safety associates and solve queries
- Record daily tracker of cases retrospective review of cases
- Maintain medical and pharmacovigilance expertise through CME
Medical Officer
Sir H. N. Reliance Foundation Hospital & Research Centre
11.2018 - 10.2019
- Counsel and treat patients in unit on OPD basis
- Maintain accurate medical records in digital format and case history in detail
- Identify, fill and submit Adverse event forms to management when suspected by doctors, patients or healthcare staffs
- Follow up of patients with Chronic diseases (DM HTN) and Preventable diseases (Anemia Malnutrition)
- Do cancer screenings including oral, breast and cervical cancers
- Participated in Women’s Day Health Camp, Geriatric Health Camp
- Arrange special camps for children (nutrition support camps), women (Anemia screening), Employees
- Supervised a team of 10 healthcare professionals within the unit
- Present and explain health related concepts in monthly meetings
- Present views and discuss innovative ideas about program for continuous improvement and implementation
Medical Officer
Rural Hospital
09.2017 - 09.2018
- Manage OPD, IPD and emergency patients
- Maintain accurate medical records and document patient case history in detail
- Identify and report any adverse event in hospital
- Provide vaccinations and ANC mother check ups
- Implement National Rural Health Mission and various government schemes
Education
MBA - Hospital Administration and Healthcare Management
Dr. D. Y. Patil Vidyapeeth
Pune, IndiaMBBS -
Grant Government Medical College
Mumbai, IndiaSkills
- Project Management
- Leadership
- Time Management
- Problem Solving
- Excel
- Word
- PowerPoint
- Critical Thinking
- Attention to Detail
- Mentorship
- Interpersonal Communication
- Expert in Client Handling and Relationship
- Signal Detection
- Risk Management
- Effective multitasking
Certification
- Certificate course in Pharmacovigilance Aggregate Reporting
- Certificate course in Signal Detection and Management in Pharmacovigilance
Languages
Marathi
English
Timeline
Medical Safety Scientist
Qinecsa Solutions
12.2020 - Current
Medical Reviewer
Tata Consultancy Services
10.2019 - 11.2020
Medical Officer
Sir H. N. Reliance Foundation Hospital & Research Centre
11.2018 - 10.2019
Medical Officer
Rural Hospital
09.2017 - 09.2018
MBA - Hospital Administration and Healthcare Management
Dr. D. Y. Patil Vidyapeeth
MBBS -
Grant Government Medical College
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