プロフィール詳細

プロジェクトを作成

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Roberta V.に依頼

Italy

Freelance medical writer/Expert in Pharmacology and Regulatory affairs

プロフィール概要

Detail-oriented medical professional with robust background in pharmacovigilance, clinical monitoring, and regulatory affairs, supported by advanced academic training in pharmacology and pharmaceutical sciences. Demonstrated strong foundation in clinical research and hospital pharmacy, particularly within oncology settings, with proven expertise in co-ordinating clinical trials and ensuring compliance with regulatory standards. Skilled in managing regulatory documentation, technical laboratory oversight, and navigating complex national/international regulatory frameworks. Instrumental in interpreting and applying evolving pharmacological guidelines and safety reporting requirements to support drug development and post-marketing surveillance.

専門分野

• ★ Pharmacovigilance/Drug Safety Monitoring
• ☆ Pharmacy
• ☆ Pharmacy Education
• ☆ Clinical Pharmacy
• ☆ Drug Development
• ☆ Pharmaceutical Regulatory Affairs
• ☆ Clinical Trials
• ☆ Regulatory Affairs

サービス

• Writing
• Consulting
• Product Development

Writing Clinical Trial Documentation, Medical Writing

Consulting Scientific and Technical Consulting

Product Development Product Evaluation

職務経験

Regulatory affairs Manger

3V SIGMA

1月 1994 - 1月 2004

Executive Regulatory Affairs

PH&T

9月 1992 - 4月 1994

Clinical Research Associate (phase III studies)

CILAG (JANSSEN GROUP)

1月 1990 - 7月 1992

学歴

Master in Pharmacy

Milan University

10月 1984 - 7月 1989

認定資格

• Pharmacology Certification (Ph.D)

  University of Pavia School of Medicine

  1月 1990 - 現在