KAVERI GAUTAM
Summary
Demonstrated success in compiling and interpreting bioinformatics information by leveraging software, statistics and data mining. Effective at maintaining current understanding of field trends, technological advances and new computational and modelling techniques. Expert R software user. Detail-oriented Laboratory Technician with experience at high-volume output labs. Skilled handling soil and water samples and maintaining laboratory equipment. Strong communication skills and talented working positively with scientific teams.
Overview
4
4
years of professional experience
Work History
Laboratory Assistant and Analyst
Eurofins Environment Testing Australia Pty Ltd
06.2022 - Current
- Loading samples on instruments to yield result according to the test required, work experience in dealing with biochemistry reagents.
- Analyzing Mass Hunter and GC results for soil and water samples
- Understanding sequencing and loading arrangement on purgent trap instrument using software like Mass Hunter and TekLink
- Performing routine analysis, validations and project work in an efficient and effective manner
- Ensuring efficient utilisation of laboratory materials
- Operating, calibrating and maintaining equipment/instruments as required
- Completing all quality control records in accordance with quality requirements and work instructions
- Contributing to the continuous improvement of their work area and processes, aiming for better safety, quality, turn-around-time and efficiency
- Performing instrument calibration and maintenance
Trial Master File(TMF) Document Specialist I
Syneos Health Clinical Solutions
01.2021 - 06.2022
- Process the study documentation in accordance with Standard Operating Procedures (SOPs), Work Instructions (Wis), GCP, ICH guidelines and study specific TMF Plans
- Support the set-up, maintenance, and closure of TMF repositories
- Participates in preparation/reconciliation of TMF documentation related to audits, inspections, and shipments
- Support documentation collection activities, including: Document scanning and indexing for trial using an electronic TMF
- Document filing for trials using a paper TMF
- Maintain compliance with company requirements (e.g., time-tracking, training)
- Participates in study-specific training as required
- Ensures the security and compliance of all documents related to active and archived projects
- Hands-on Experience with Veeva Vault (Document processing software).
Pharmacovigilance Associate
Syneos Health
06.2020 - 01.2021
- Assessment of case reports for seriousness, causality and expectedness
- Well versed with Pharmacovigilance concepts and Reporting guidelines of ICH, GVP and CIOMS
- Participated in the case review process applying a high standard of quality review to ensure sound medical safety data documentation
- Knowledge of Case Triage, Case Narrative writing, performing Labelling/ Listedness and Causality determination
- Even learn about Medical Coding (MedDRA) of adverse events, indications, and Medical history
- Understanding of Drug Development Process including Drug safety and different Phases of Clinical Trials.
Education
Master of Science - Systems Biology And Bioinformatics
Punjab University
06.2019
Bachelor of Science - Bioinformatics (Hons)
Punjab University
06.2017
Skills
- ICSR processing
- Causality Assessment
- Drug Development
- Narrative writing
- MedDRA
- Wingspan
- Sterilization techniques
- Laboratory safety protocols
- Data analysis
- Laboratory techniques
- Specimen Processing
- Pharmacovigilance Trainee
Websites
Training
- Participated in GIAN (global initiative for academic network) on Genome Informatics organized by Panjab University, India- 2018.
- Workshop on a foundation program and application of Data Science in Biology using Tibco Statistica organized by Panjab University, India- 2019.
- Workshop on Machine Intelligence and deep learning (MIDL-2019) organized by CSIR- Central Scientific Instruments Organization held at CSIR-CSIO, India.
- Workshop on Personality Development and Communication Skills organized by Central Placement cell, India.
Accomplishments
- Pursued Qualified Pharmacovigilance Professional Training in
- case processing from Academy of Clinical Intelligence (a
- Pharmacovigilance Training Management Company), India.
- Successfully completed dissertation work (6 months) on
- "DIFFERENTIAL GENE EXPRESSION STUDIES OF ESTRADIOL
- TREATED BREAST CANCER TIME COURSE DATA THROUGH R/BIOCONDUCTOR AND PATHWAY MAPPING BY NETWORK BIOLOGY".
References
Available on request
Timeline
Laboratory Assistant and Analyst
Eurofins Environment Testing Australia Pty Ltd
06.2022 - Current
Trial Master File(TMF) Document Specialist I
Syneos Health Clinical Solutions
01.2021 - 06.2022
Pharmacovigilance Associate
Syneos Health
06.2020 - 01.2021
Master of Science - Systems Biology And Bioinformatics
Punjab University
Bachelor of Science - Bioinformatics (Hons)
Punjab University
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