プロフィール詳細

プロジェクトを作成

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Deepika D.に依頼

India

Experienced Medical Safety Writer & Scientist | 6+ Years in Pharmacovigilance | Clear, Engaging Content

プロフィール概要

Deepika Doshi | Medical Safety Writer & Safety Scientist I am a licensed pharmacist with over six years of experience in medical research and safety medical writing. My expertise includes: • Scientific writing and editing • Case analysis and summarization • Literature reviews and systematic reviews • Adverse event research and signal evaluation • Pharmacovigilance and safety reporting I have successfully completed diverse projects including research articles, case reports, signal evaluation reports, validation assessment reports, and research proposals. My specialization in systematic reviews, and primary research writing allows me to offer tailored assistance in these areas. With a strong background in pharmacology and a keen eye for detail, I excel at translating complex medical information into clear, accurate, and compliant safety documentation. As an esteemed medical writer, i have expertise in below areas: Signal detection Writing Periodic Safety Update Reports (PSURs) Developing Development Safety Update Reports (DSURs) Composing Risk Management Plans (RMPs) Preparing Individual Case Safety Reports (ICSRs) Signal Detection and Evaluation: (Qualitative and Quantitative methods) Assisting in the preparation of signal evaluation reports Summarizing safety signals and their potential impact Screening of Regulatory websites (PRAC, ChMP, CMDh, FDA) Literature Review: Conducting systematic literature searches Analyzing and summarizing relevant scientific publications Identifying potential safety signals from published literature Regulatory Documentation: Contributing to safety sections of regulatory submissions (e.g., New Drug Applications, Marketing Authorization Applications) Preparing responses to regulatory authority questions related to safety Safety Narratives: Writing detailed narratives for serious adverse events or cases of special interest Ensuring consistency and accuracy in case presentations Aggregate Data Analysis: Contributing to the interpretation and presentation of aggregate safety data Assisting in the preparation of safety sections for clinical study reports Standard Operating Procedures (SOPs): Developing and maintaining SOPs and WIs related to safety writing and documentation Training Materials: Creating training materials on pharmacovigilance writing for internal teams Cross-functional Collaboration: Working closely with physicians, statisticians, and other subject matter experts to ensure accurate and comprehensive safety reporting Quality Control: Performing quality checks on safety documents Ensuring compliance with regulatory requirements and internal standards Database Management: Utilizing safety databases and pharmacovigilance systems for data retrieval and analysis If you require any of the aforementioned services, please feel free to reach out to me I prioritize quick responses, clear communication, and strive to build positive client relationships while delivering high-quality service within my capabilities.

専門分野

• ☆ Pharmacovigilance/Drug Safety Monitoring
• ☆ Medical Writing
• ☆ Literature Review
• ☆ Traditional/Narrative Literature Review
• ☆ Systematic Literature Review
• ☆ Risk Management

サービス

• Writing
• Research

Writing Medical Writing, Audio Transcription

Research Gray Literature Search, Scientific and Technical Research, Systematic Literature Review

職務経験

Senior Medical Writer and Principal Medical Writer

Parexel International

8月 2022 - 現在

PAREXEL International (India)

8月 2022 - 現在

Senior Medical Writer and Principal Medical Writer

Amneal Pharmaceutical

7月 2021 - 8月 2022

Associate Medical Writer

Apcer Life Sciences

8月 2018 - 7月 2021

学歴

Bachelor in Pharmacy

B K Mody Government Pharmacy College

8月 2014 - 5月 2018

認定資格

• Certificate of Recognition

  Parexel Internation

  6月 2024 - 現在