プロフィール詳細

プロジェクトを作成

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devi s.に依頼

India

Freelance medical writer|Expert in regulatory and safety|Medical writer with 8+ years of experience in Pharmacovigilance

プロフィール概要

Experienced in regulatory writing, scientific writing and medical affairs in key therapeutic areas.Literature monitoring, Documents worked on include but not limited to clinical study reports, summary modules, patient narratives, protocols and protocol amendments, Investigator brochure, informed consent form, DSURs, RMPs, PSURs (PBRER format),PADER,CER,CSR, core data sheet updations (CDS), responses to health authority (HA) queries, toxicological safety assessment reports, manuscripts, slide decks and medical information responses.

専門分野

• ★ Medical Writing
• ☆ Regulatory Writing

サービス

• Writing
• Research

Writing Clinical Trial Documentation, Technical Writing

Research Systematic Literature Review

職務経験

senior drug safety associate

Accenture

2月 2011 - 1月 2020

学歴

M.Pharm

JNTUH

1月 2008 - 1月 2010

認定資格

• 認定資格の詳細は未入力です。