プロフィール詳細

プロジェクトを作成

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Darshan D.に依頼

India

Medical Writer || Clinical Researcher || Market Researcher || Digital Marketer || Health-Tech Start-up Consultant

プロフィール概要

Seasoned Pharma Professional (12+ Years) with a demonstrated history of working in diversified profiles from a registered pharmacist, Production Executive, Clinical Researcher, Medical Writer, Global Clinical Trial Project Manager, Socio-scientific Digital Marketer, Business Development Consultant and Content Writer. Currently, I am working as Independent Pharma and Research consultant. I have extensive experience in medical writing for clinical study protocols, case report forms, investigator's brochures, clinical study reports, and associated documents. During my journey as an employee, i have actively participated and was involved in clinical studies of 08 New Chemical Entities, 2 New Biological Entities, 4 Bio-similar, 27 Vaccines, and 500+ BA/BE studies (including First to File projects). My Core expertise are 1-Feasibility Assessment- Selecting Clinical study design, CRO/ Site Selection, Vendor Selection, Project Planning 2-Medical Writing (Clinical Study Protocol, Clinical Study Report, SOPs writing, Investigator brochure, Informed consent Document, Patient Dairy, Case report form) based on the different regulatory requirements. 3-Aggregate Report Writing- Periodic Safety Updated Report (PSUR), Periodic Benefit-Risk Evaluation Report (PBRER), Development Safety Updated Report (DSUR), Risk Management Plan (RMP) etc. 4-Signal Management-Signal Detection, Signal Validation & prioritization, Signal evaluation reports and track signals for products. 5-Regulatory writing- eCTD (Module 2.4 to 2.7 preparation), Summary of Product Characteristics (SmPC), Product Information Leaflets (PIL), Product Monograph (PI) etc. 6-Manuscript Writing 7-Blog, Newsletter, White Paper writing 9-Clinical Trial Design Selection 10-Project Management 11-Independent Clinical Monitoring & Auditing 12-Regulatory Compliance Check 13-Clinical Research Project Outsourcing Consulting 14-Clinical Trial Project Management 15-Vendor Management I am on a mission to upskill next-generation Clinical Researchers through the following training and workshop modules. 1-Medical Writing- Feasibility Study Design, Clinical Trial Design, Protocol writing, ICD/CRF preparation, CSR writing. 2-Clinical Research Global Regulatory Process- ICH GCP, USFDA, EMEA, DCGI etc. 3-Project Management 4-Quality Management

専門分野

• ★ Post-Market Surveillance
• ★ Clinical Trials
• ★ Medical Writing
• ☆ Data Processing
• ☆ Data Management
• ☆ Preclinical Research
• ☆ Pharmacovigilance/Drug Safety Monitoring
• ☆ Epidemiology
• ☆ Regulatory Writing
• ☆ Marketing Analytics
• ☆ Project Management

サービス

• Writing
• Research
• Data & AI
• Product Development

Writing Clinical Trial Documentation, Technical Writing, Copywriting

Research Market Research, Feasibility Study, Fact Checking, Gray Literature Search, Systematic Literature Review

Data & AI Statistical Analysis

Product Development Formulation

職務経験

CEO

Basilion Healthcare And Research

2月 2019 - 現在

Scientist

Veeda Clinical Research

7月 2016 - 1月 2019

Scientist

Veeda Clinical Research

7月 2016 - 1月 2019

Clinical Research Associate

Zydus Research Centre

11月 2011 - 7月 2016

Research Associate

Zydus Research Center

10月 2011 - 6月 2016

Research Traineeship

Torrent Research and Development Centre

1月 2011 - 10月 2011

Trainee

Torrent Research and Development Centre

1月 2011 - 9月 2011

学歴

Master in Pharmacy

Gujarat Technological University

6月 2009 - 7月 2011

認定資格

• Good Clinical Practice

  Veeda

  5月 2011 - 現在