プロフィール詳細

プロジェクトを作成

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Dr. Tanvi D.に依頼

India

Clinical Research Specialist | ICMR Trial Data Management | REDCap & VigiFlow Expert | PharmD

プロフィール概要

I am a PharmD graduate with hands-on experience in ICMR-approved clinical research, specializing in data management, regulatory compliance, and pharmacovigilance. I collaborate with biotech companies, CROs, academic researchers, and healthcare startups to streamline clinical workflows, strengthen regulatory alignment, and ensure high-quality data outputs. My expertise spans clinical trial operations, including protocol review, feasibility assessment, study design evaluation, and documentation compliant with ICH-GCP, Schedule Y, and FDA 21 CFR Part 11. I offer extensive capabilities in data management and REDCap, covering eCRF design, variable mapping, data validation, query automation, data cleaning, and database locking, along with familiarity in MedDRA. My pharmacovigilance competencies include adverse event case processing, VigiFlow management, medical coding, SAE triage, ICSR development, narrative writing, and regulatory safety submissions. I also provide scientific and medical writing support across clinical study reports, manuscripts, regulatory dossiers, CTD-related documents, protocols, and informed consent forms. With more than two years of clinical trial experience encompassing multicentric trial data management, safety monitoring, regulatory correspondence, and inspection readiness. I bring strong technical knowledge, REDCap certification, proficiency in SAS, and a comprehensive understanding of global regulatory guidelines to every project.

専門分野

• ★ Clinical Trials
• ★ Clinical Data Management
• ★ Pharmacovigilance/Drug Safety Monitoring
• ☆ Clinical Trial Site Selection & Monitoring
• ☆ Clinical Trials Data Analysis
• ☆ Regulatory Affairs
• ☆ Medical Writing
• ☆ Healthcare Communications
• ☆ Patient Education Materials
• ☆ Research Summaries & Abstracts
• ☆ Technical & Scientific Writing
• ☆ Journal Selection
• ☆ Manuscript & Journal Article Writing
• ☆ SOP & Protocol Writing
• ☆ Case Studies

サービス

• Writing
• Research
• Consulting

Writing Clinical Trial Documentation, Medical Writing, Non-Medical Regulatory Writing, Technical Writing, Business & Legal Writing, Creative Writing, Newswriting, Audio Transcription, General Proofreading & Editing

Research Market Research, Meta-Research, Scientific and Technical Research

Consulting Healthcare Consulting

職務経験

ICMR Research Intern

Sri Aurobindo Institute of Medical Sciences

8月 2024 - 7月 2025

Pharm D Intern

Sri Aurobindo Institute of Medical Sciences

7月 2024 - 7月 2025

Intern

Sri Aurobindo Institute of Medical Sciences

9月 2019 - 7月 2025

Last Mile Healthcare Intern

Avenida Innovations

9月 2024 - 4月 2025

Nutrition Officer Trainee

Nestlé Nutrition

5月 2024 - 7月 2024

学歴

Doctor of Pharmacy (PharmD)

Sri Aurobindo Institute of Pharmacy, Indore (RGPV University)

9月 2019 - 7月 2025

Pharm D (Pharmacy)

Sri Aurobindo Institute of Medical Sciences

9月 2019 - 7月 2025

認定資格

• Clinical Trial Analysis & Reporting

  Internshala Trainings

  1月 2025 - 現在

• Clinical Diagnostics for Clinical Pharmacists

  Climed Research Solutions

  1月 2024 - 現在

• SAS Programming for Clinical Data Management

  Internshala Trainings

  7月 2023 - 現在

• ICH-GCP E6 (R3) & Biomedical Ethics

  Climed Research Solutions

  12月 2023 - 12月 2025

出版物

JOURNAL ARTICLE

Dabhade T, Gupta A, Parashar A, Indhurkhya A. Optimizing Antibiotic and Analgesic Prescribing Patterns in Surgical Care: A Prospective Study on Guideline Adherence. ijnrph [Internet]. 2024 Dec. 31 [cited 2025 May 27];2(2):64-72. Available from: https://www.ijnrph.com/index.php/ijnrph/article/view/103 .