Profile Details

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USD 60 /hr

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Hire Dr. Tanvi D.

India

USD 60 /hr

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

Profile Summary

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.

Subject Matter Expertise

• ★ 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

Services

• 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

Work Experience

ICMR Research Intern

Sri Aurobindo Institute of Medical Sciences

August 2024 - July 2025

Pharm D Intern

Sri Aurobindo Institute of Medical Sciences

July 2024 - July 2025

Intern

Sri Aurobindo Institute of Medical Sciences

September 2019 - July 2025

Last Mile Healthcare Intern

Avenida Innovations

September 2024 - April 2025

Nutrition Officer Trainee

Nestlé Nutrition

May 2024 - July 2024

Education

Doctor of Pharmacy (PharmD)

Sri Aurobindo Institute of Pharmacy, Indore (RGPV University)

September 2019 - July 2025

Pharm D (Pharmacy)

Sri Aurobindo Institute of Medical Sciences

September 2019 - July 2025

Certifications

• Clinical Trial Analysis & Reporting

  Internshala Trainings

  January 2025 - Present

• Clinical Diagnostics for Clinical Pharmacists

  Climed Research Solutions

  January 2024 - Present

• SAS Programming for Clinical Data Management

  Internshala Trainings

  July 2023 - Present

• ICH-GCP E6 (R3) & Biomedical Ethics

  Climed Research Solutions

  December 2023 - December 2025

Publications

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 .