CHANDRA RAJ GIRI
South Richmond Hill,NY
Summary
PharmD graduate with an MS in Clinical Trial Management and advanced certification in Pharmacovigilance. Hands-on experience in medication safety surveillance, ICSR processing, and EDC systems management. Seeking a role in Pharmacovigilance to leverage clinical expertise and support patient safety initiatives.
Overview
1
1
Certification
12
12
years of professional experience
Work History
Clinical Research Intern
Northwell Health - North Shore University Hospital (NSUH)
Manhasset, USA
09.2025 - 12.2025
- Managed REDCap EDC for active trials, ensuring accurate data entry, resolving queries, and following up on case discrepancies
- Reviewed trial cases for protocol adherence, identifying and flagging necessary corrections to maintain compliance
- De-identified patient data according to FDA 21 CFR Part 11 and HIPAA standards to ensure confidentiality.
- Maintained regulatory binders and tracking logs, ensuring organization and accessibility of pre-screening documentation
- Participated in protocol training sessions and created investigator binders
- Completed GCP, HIPAA, and CITI certifications
Clinical Pharmacist
Baptish Hospital
Bangalore , Karnataka, India
01.2014 - 03.2018
- Evaluated patient medical records for drug allergies, interactions, and contraindications, ensuring safe and effective medication therapy.
- Collaborated in clinical rounds to develop and refine patient care strategies, contributing to improved treatment outcomes.
- Delivered comprehensive drug information to medical staff and patients, enhancing understanding of medication management.
- Investigated drug information requests from health care providers including indications, dosing regimens, contraindications, interactions, adverse reactions.
Education
Master of Science - Clinical Trial Management
CUNY York College
Jamaica, NY12-2025
Doctor of Pharmacy -
Rajiv Gandhi University of Health Sciences
India10-2018
Skills
- Pharmacovigilance
- Argus safety
- Drug safety expertise
- ICSR Processing
- Case processing
- Adverse event reporting
- Event assessment
- Signal Detection
- Safety protocols
- Safety Documentation
- Narrative Development
- MedDRA coding
- Pharmacovigilance regulations
- Post-marketing surveillance
- PADER/PBRER/PSUR/DSUR
- Risk Management Plans
- Risk management strategies
- Regulatory & Compliance
- Regulatory Reporting
- Regulatory Submissions
- Global Regulations
- International Regulations
- Regulatory Agencies
- Compliance Standards
- Compliance Knowledge
- GCP Compliance
- HIPAA
- 21 CFR Part 11
- Good Manufacturing Practice (GMP)
- Submission Processes
- Inspection Preparation
- Compliance Readiness
- Corrective and Preventive Action (CAPA)
- Quality Management
- Quality assurance techniques
- ALCOA
- Drug labeling review
- Clinical research
- Clinical data management
- Clinical Standards
- Clinical Guidelines
- Trial Oversight
- Clinical trial monitoring
- REDCap Proficiency
- Castor EDC
- Argus Safety
- Data Analysis Tools
- Statistical Analysis
- Research Techniques
- Research Articles
- Consent process
- Pharmacokinetics
- Pharmacodynamics
- Medical writing
- Reporting Standards
- Timely Reporting
- Effective communication
- Team collaboration
- Problem solving
- Problem resolution
- Time management
- Continuous learning mindset
- Medical terminology
Languages
- English, Professional proficiency
- Nepali, Native/Fluent
- Hindi, Fluent
Degree
- Doctor of Pharmacy (PharmD)
- MS in Clinical Trial management (CTM)
Key Academic Projects
- Systematic Review - Mavacamten (Capstone, CTM 510), Synthesized efficacy and safety data from multiple clinical trials for FDA-approved hypertrophic cardiomyopathy drug. Extracted and categorized AEs/SAEs.
- Phase 3 Protocol - Tofacitinib (Medical Writing Course), Authored complete Phase 3 protocol: randomized, double-blind, placebo-controlled JAK inhibitor study in rheumatoid arthritis with methotrexate withdrawal. Defined safety monitoring parameters, AE reporting timelines, and stopping rules.
- EDC Build - Castor (Clinical Data Management Course, CTM 508), Built fully functional EDC system by abstracting data requirements from a clinical trial protocol. Created validation rules and edit checks - simulating real-world CDM and PV data quality workflows.
- Medication Safety Study (PharmD Thesis), Prospective observational study of medication errors in tertiary care hospital. Performed root-cause and risk factor analysis.
Certification
- Advanced Pharmacovigilance and Regulatory Affairs (APVASC), CCRPS, CPD-accredited #50670, 01/25 - 12/27
- ICH GCP (E6[R2]) - U.S. FDA Focus, CITI Program, Certified
- Human Subjects Research (HSR), CITI Program, Certified
- Responsible Conduct of Research (RCR), CITI Program, Certified
- Conflict of Interest (COI), CITI Program, Certified
- MedDRA Introductory and Advance Coding Training, MedDRA (MSSO), Completed
Timeline
Clinical Research Intern
Northwell Health - North Shore University Hospital (NSUH)
09.2025 - 12.2025
Clinical Pharmacist
Baptish Hospital
01.2014 - 03.2018
Master of Science - Clinical Trial Management
CUNY York College
Doctor of Pharmacy -
Rajiv Gandhi University of Health Sciences