ABIRAMI KANNAN
Pune,Maharashtra
Summary
Results-oriented Life Science and Healthcare Technology Professional with 1+ year of experience in clinical research, clinical data management, and pharmacovigilance. Proven knowledge of ICH-GCP, GVP, and international regulatory standards (FDA, EMA). Skilled in case processing, safety data analysis, and clinical documentation. Adept in EHR systems, CRF design, and signal detection. Demonstrated ability to collaborate with cross-functional teams and deliver high-quality, compliant documentation to support drug safety and clinical operations.
Overview
2
2
years of professional experience
1
1
Certification
Work History
Intern - Clinical Research, CDM & Pharmacovigilance
Clin Bioscience
Chennai, Tamil Nadu
05.2025 - Current
- Designed and tested CRFs and DMPs as per protocol requirements for mock Phase II/III trials.
- Gained hands-on experience using Medidata Rave, Oracle Clinical, EDC, and CTMS systems.
- Performed safety data cleaning, reconciliation, and coding using MedDRA in simulated clinical environments.
- Contributed to adverse event documentation, ensuring compliance with GVP and regulatory guidelines.
- Created SOPs and maintained audit-ready documentation.
Clinical Analyst - Oncology Projects
Navya Care
Bangalore, Karnataka
06.2021 - 06.2022
- Supported clinical decision-making for oncology care based on NCCN and NCG guidelines.
- Collaborated with clinicians to manage patient documentation, case summaries, and treatment pathways.
- Designed and delivered training materials for healthcare staff on clinical platforms.
- Ensured HIPAA-compliant handling of patient records; maintained >99% accuracy in documentation.
- Identified process gaps and proposed digital solutions, increasing data integrity and clinician adoption by 25%.
Project Trainee - Nanobiotechnology Research
Dr. D Y Patil Biotechnology Institute
Pune, Maharashtra
01.2020 - 05.2020
- Conducted experimental studies on tissue regeneration using nanoparticles under GLP conditions.
- Documented experimental protocols, safety procedures, and outcomes for scientific reporting.
Industrial Trainee - Food Technology and Microbiology
Rapture Biotech
Pune, Maharashtra
06.2019 - 07.2019
Education
M.Tech - Biotechnology
VIT University
06.2022
B.Tech - Biotechnology
Dr. D Y Patil Institute
05.2020
Skills
- CRF Design
- DMP Development
- AE/SAE Reconciliation
- Source Documentation
- Data Entry
- Clinical Trial Phases
- Investigator Brochures
- Case Processing
- Narrative Writing
- MedDRA Coding
- Signal Detection
- Safety Database (Oracle Argus/ARISg)
- GVP
- FDA Compliance
- EMA Compliance
- CDMS
- EDC (Medidata Rave, Oracle Clinical)
- Data Cleaning
- Query Management
- CTMS
- EHR Implementation
- HIPAA Compliance
- Patient Safety Standards
- Clinical Decision Support Tools
- CAPA
- Quality Checks
- Training Support
- KPI Monitoring
- SOP Documentation
- MedDRA
- Lab Calculations for Quality Control and Assurance
Websites
Certification
ICH-GCP Certified, NIH/National Institute on Drug Abuse, 2025-06-01, 2028-06-01
Languages
English
Tamil
Hindi
Marathi
Work Authorization
Open to relocate or work in hybrid settings
Personal Information
Availability: Open to relocate or work in hybrid settings
Timeline
Intern - Clinical Research, CDM & Pharmacovigilance
Clin Bioscience
05.2025 - Current
Clinical Analyst - Oncology Projects
Navya Care
06.2021 - 06.2022
Project Trainee - Nanobiotechnology Research
Dr. D Y Patil Biotechnology Institute
01.2020 - 05.2020
Industrial Trainee - Food Technology and Microbiology
Rapture Biotech
06.2019 - 07.2019
M.Tech - Biotechnology
VIT University
B.Tech - Biotechnology
Dr. D Y Patil Institute
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