Kajal Jagtap
Summary
- Results-oriented Analyst skillful in managing and breaking down large volumes of information. Proactive at heading off issues in operations, workflow and production by uncovering trends affecting business success.
- Enthusiastic Assistance offers background in problem-solving while serving in multiple roles. Assist organizational efforts with attention to detail and courtesy. Brings organized attitude to completing tasks, entering data and coordinating with team and come up with solution.
Overview
5
5
years of professional experience
Work History
Safety Science Analyst- Post Marketing Safety
Fortrea (Previously As LabCorp)
04.2021 - 11.2023
- Executing Pharmacovigilance safety management process- A combination of case intake, Duplicate search, Case entry, medical coding, Narrative waiting, Case follow-up.
- Proficient in using global safety database: - Oracle ARGUS.
- Well versed with MedDRA and WHO Drug Dictionary.
- Expert in case processing of literature, Legal and other case type.
- Through knowledge of PSUR, DSUR, PBRER, PADER.
- Collaborated with cross-functional teams to identify opportunities for process improvement and increased efficiency.
- Recommended process improvements to continually identify, analyze and fix constraints and challenges.
Clinical Research Coordinator
Oyster & Pearl Hospital
07.2020 - 10.2020
- Complied trail related documents into a master file as required by sponsored or regulatory agency.
- Provided guidance on good clinical practice regulation and other applicable regulatory standards.
- Collaborated with Internal Department such as Regulatory Affairs and Data Management to ensure that all studies were conducted in accordance with ICH-GCP guidelines.
- Assisted in preparing periodic report, summarizing progress of clinical studies.
- Developed and maintained accurate and timely study databases.
- Conducted routine visit to research sites to ensure compliance with protocol requirements
- Performed patient assessments collected and analyze data, and prepared reports.
- Monitored patient safety during clinical trials according to established guidelines.
- Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
- Reduced data entry errors by implementing stringent quality control measures throughout the study lifecycle.
- Maintained accurate and up-to-date case report forms and source documents for traceability.
Training Coordinator
Megafine Pvt Ltd
06.2018 - 07.2018
- Completed basic industrial training working and coordinating with industry employees to understand manufacturing process of API (Active Pharmaceutical Ingredient) drugs.
- Evaluated success of training programs and recommended improvements to upper management to enhance effectiveness.
Education
Post Graduate Diploma in Management - Pharmacovigilance & Clinical Data Management
MITCON Biotechnology & Pharmaceutical Center
Pune12.2019
Bachelor of Pharmacy - Medicinal And Pharmaceutical Chemistry
SMBT
Nashik06.2019
H.S.C - Science Education, India
Higher Secondary School
Nashik04.2014
Skills
- Oracle ARGUS V82
- Glenmark App Portal
- Business Operations Analysis
- MS Excel
- Excel proficiency
- Data Research and Validation
- Analytical Thinking
- Process Improvements
- Documentation And Reporting
Languages
English
Advanced (C1)
Hindi
Advanced (C1)
Marathi
Bilingual or Proficient (C2)
Timeline
Safety Science Analyst- Post Marketing Safety
Fortrea (Previously As LabCorp)
04.2021 - 11.2023
Clinical Research Coordinator
Oyster & Pearl Hospital
07.2020 - 10.2020
Training Coordinator
Megafine Pvt Ltd
06.2018 - 07.2018
Post Graduate Diploma in Management - Pharmacovigilance & Clinical Data Management
MITCON Biotechnology & Pharmaceutical Center
Bachelor of Pharmacy - Medicinal And Pharmaceutical Chemistry
SMBT
H.S.C - Science Education, India
Higher Secondary School
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