Profile Details

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USD 25 /hr

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Hire devi s.

India

USD 25 /hr

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

Profile Summary

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.

Subject Matter Expertise

• ★ Medical Writing
• ☆ Regulatory Writing

Services

• Writing
• Research

Writing Clinical Trial Documentation, Technical Writing

Research Systematic Literature Review

Work Experience

senior drug safety associate

Accenture

February 2011 - January 2020

Education

M.Pharm

JNTUH

January 2008 - January 2010

Certifications

• Certification details not provided.