Microsoft word
Neha D
Clical Research
Bengaluru,KA
Summary
B.Pharmacy graduate with a strong background in Clinical Research, Clinical Data Management, and Pharmacovigilance, complemented by training in ICH-GCP, GVP, ICH E2A-E2F, and ICSR processing. Proficient in narrative writing, CRF/eCRF review, and clinical trial documentation, demonstrating meticulous attention to detail and adherence to regulatory standards. Committed to enhancing data integrity and patient safety while supporting regulatory compliance in entry-level clinical research roles. Prepared to leverage academic knowledge and practical skills to contribute effectively to a dynamic research team.
Overview
2
2
years of professional experience
2
2
Certifications
1
1
Language
Work History
Volunteer
Sarani Bio Integra Pvt.Ltd
06.2023 - 11.2025
- Assisted with special events and programs.
- Maintained clean, neat, and operational facilities to serve program needs.
- Supported engaging, fun, and smooth-running events by helping with organization and planning.
- Used strong interpersonal communication skills to convey information to others.
- Managed over 50 datasets per day which increased the result efficiency.
Education
B. Pharmacy - B Pharma
Visveswarapura Institute of Pharmaceutical Sciences
Bengaluru01.2025
Intermediate - undefined
CliniWings Junior College
01.2025
Skills
Clinical Research: ICH-GCP Guidelines, Clinical Trial Phases (0–IV), Protocol & CSR, Ethics (IRB/IEC, Declaration of Helsinki, Belmont Report), Randomized Trial, Blinding, Biasness, Centralised/Decentralised Trials, IRT, CRA/CRC/ Sponsor/Investigator, TMF/e-TMF, Informed Consent (ICF), CRF, CFR Regulations
Clinical Data Management: eCRF Design, Database Setup, Data Entry, Data Review, Edit Checks, UAT, Query & Discrepancy Management, SAE Reconciliation, Medical Coding, Clean File Declaration, Database Lock, 21 CFR 11
Pharmacovigilance / Drug safety: AE/ADR, SAE/SUSAR, MedWatch, Yellow Card, EudraVigilance, ICSR Case Processing, Narrative Writing, CIOMS, GVP, WHO-UMC & Naranjo Causality, Signal Detection, Aggregate Reports (DSUR, PSUR, PADER, PBRER), MedDRA, WHO-DDE
Medical Writing: Regulatory Writing (Protocols, CSRs, Safety Reports), Scientific Writing (Manuscripts, Posters, Abstracts), Medico-Marketing Content, Literature Search (PubMed, EMBASE, Scopus, Cochrane, Medline, ClinicalTrialsgov)
Regulatory Affairs: DMF, Dossiers (IND, IMPD, NDA, ANDA, BLA, MAA), eCTD (Modules 1–5), Regulatory Submissions, Regulatory Compliance
Tools: Argus, Aris-G, Rave, MACRO, Oracle Clinical, LifeSphere, Veeva Vault
Good communication and interpersonal skills
MS office ( Word,PPT & Excel) , ERP system, Email and Documentation & Data analysis
Strong team work and collaboration skills, Flexible and Deadline-driven
Adaptable, self motivated, Leadership ability , Time management , Patience & Multitasking
Clinical Research and Clinical Data Management
Pharmacovigilance
Medical writing
Regulatory affairs
Secondary clinical research
Software
Microsoft Excel
Microsoft powerpoint
Certification
“3 Months Advanced Diploma in Clinical Research, Clinical Data Management, Pharmacovigilance, Medical Writing, and Regulatory Affairs”
Interests
Sports
Timeline
Volunteer
Sarani Bio Integra Pvt.Ltd
06.2023 - 11.2025
Intermediate - undefined
CliniWings Junior College
B. Pharmacy - B Pharma
Visveswarapura Institute of Pharmaceutical Sciences
Internships Certificates
- Volunteer for clinical trials ( PT and RIPT)
- Sarani Bio-integra Pvt.Ltd
- Conducted Patch test (PT) and Repeat insult patch test (RIPT) at clinical centre for cosmetic products and testing process for 32 distinct formulations comprising leave on and wash of cosmetic products.
- 1-Month Internship
- CliniWings Clinical Research Pvt Ltd – Online | November 2025
- Clinical Research, ICH-GCP, Ethics, Pharmacovigilance, ICSR Processing, Clinical Data Management Activities, Regulatory & Scientific Writings, Dossiers, e-CTD, and Regulatory Compliance.
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