Surajit Bhattacharyya
Kolkata
Summary
Experienced professional with over 6 years in clinical research and pharmaceuticals, adept in
quality control, clinical trial coordination, and drug safety. Demonstrated expertise in ensuring
legal compliance, streamlining procedures, and optimizing pharmacovigilance protocols,
resulting in a 30% reduction in adverse event reporting timeframes. Committed to taking on a
demanding role in clinical operations to generate significant change and enhance healthcare
initiatives.
Overview
8
8
years of professional experience
Work History
Safety & PV Specialist I
Syneos Health
10.2023 - 04.2024
- Enhanced efficiency by implementing PVG quality and tracking systems, resulting in a 20% reduction in ICSR processing time
- Evaluated and triaged ICSR data, ensuring completeness and accuracy, thus improving pharmacovigilance practices
- Maintained compliance with SOPs and regulatory guidelines, contributing to the generation of expedited reports for clinical trials and post-marketing programs.
Senior Process Executive Pharmacovigilance
Cognizant Technology Solution
Kolkata
07.2021 - 09.2023
- Oversaw diverse adverse drug reactions (ADRs) and safety data, ensuring compliance with regulatory standards, and company policies
- Managed case processing for multiple report types, maintaining adherence to regulatory timelines which resulted in overall compliance by 25%
- Acknowledged by clients for enhanced pharmacovigilance processes, staying updated on regulatory guidelines, and providing training to team members, contributing to continuous improvement.
Clinical Research Coordinator
Institute of Neurosciences Kolkata
Kolkata
03.2019 - 07.2021
- Collaborated with investigators and sponsors to plan trials, develop protocols, and implement recruitment strategies, optimizing trial setup
- Recruited eligible participants with adherence to criteria, ensuring informed consent and protocol compliance, which ensures the decrease of error in patient recruitment by 30%
- Managed day-to-day trial operations, emphasizing data accuracy, protocol adherence, and regulatory compliance, while promptly addressing adverse events
- Demonstrated hands-on experience using various visual analogue scales (eCssrs, Midas
- EQ5D5L, HIT6, BDI II, SSQOL, MOCA, BI, mRS, NIHSS) during screenings and patient visits following protocol requirements
- Clinical Trials Experience as Un-blinded Pharmacist
- Implemented randomization procedures, ensuring adherence to trial protocols and compliance standards
- Dispensed doses according to protocol, maintaining accountability for drugs and placebos with strict adherence to guidelines
- Monitored patient details and dose intervals meticulously, maintaining accuracy and compliance while facilitating effective communication within the trial team for data integrity.
Quality Control Analyst
Holy Cross Research Laboratories
Kolkata
08.2016 - 03.2018
- Supervised quality control operations, ensuring adherence to safety standards and conducting visual inspections for finished products
- Provided extensive training and support to analysts, facilitating the effective performance of laboratory procedures and assays
- Participated in internal assessments and audits, resolving equipment issues proficiently, and evaluating new technologies for optimal utilization.
Education
Master of Business Administration -
SVKM's Narsee Monjee Institute of Management Studies (NMIMS)
Jan -2022
Certificate in Clinical Research in Hospitals -
BCDA College of Pharmacy and Technology (West Bengal University of Technology)
Aug 2018
Bachelor of Pharmacy -
Jadavpur University to AMRI Hospital
Aug 2015
Skills
- Soft Skills:
- Observational Skills
- Decision-making in Time-Sensitive
- Environments
- Effective Communication across
- Multidisciplinary Teams
- Exceptional Multi-tasking Abilities
- SOP Adherence & Implementation
- Drug/Biologic/Device Regulations
- Clinical Data Collection & Analysis
- Adverse Event Assessment
- Case Processing & Coding
- Database & Software Proficiency:
- ArisG
- Argus
- Veeva Vault Safety
- Rave Classic & Rave EDC
- Medidata Rave
- SAS Studio & SAS Enterprise
- Cenduit
- Quintiles Infosario
- REDCap
- ERT Global
Certification
ICH Good Clinical Practice E6 (R2) by The Global Health Network
Good Clinical Practice by NIDA Clinical Trial Network
Data Management for Clinical Research by Vanderbilt University
Introduction to Collecting and Reporting Adverse Events in Clinical Research by The Global
Health Network
SAS Programming 1: Essentials ∙Data Literacy Essentials ∙Data Literacy in Practice
ADDITIONAL QUALIFICATION / ACHIEVEMENT /CERTIFICATION
Participated as a competitor in “the 18th West Bengal State Karate-Do Championship”, in
Completed 5th color belt in karate, Gi Toku Kai Karate-Do India, in 2013
Approved as competent technical staff by the Government of West Bengal Department of
Health & Family Welfare Directorate of Drugs Control, in 2017
Participated and presented a scientific poster in the National Seminar on “Clinical Research in
Recent Pharmaceutical Science”, Jadavpur University, in 2017.
Timeline
Safety & PV Specialist I
Syneos Health
10.2023 - 04.2024
Senior Process Executive Pharmacovigilance
Cognizant Technology Solution
07.2021 - 09.2023
Clinical Research Coordinator
Institute of Neurosciences Kolkata
03.2019 - 07.2021
Quality Control Analyst
Holy Cross Research Laboratories
08.2016 - 03.2018
Master of Business Administration -
SVKM's Narsee Monjee Institute of Management Studies (NMIMS)
Certificate in Clinical Research in Hospitals -
BCDA College of Pharmacy and Technology (West Bengal University of Technology)
Bachelor of Pharmacy -
Jadavpur University to AMRI Hospital
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