Profile Details

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USD 40 /hr

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Hire Roberta V.

Italy

USD 40 /hr

Freelance medical writer/Expert in Pharmacology and Regulatory affairs

Profile Summary

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.

Subject Matter Expertise

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

Services

• Writing
• Consulting
• Product Development

Writing Clinical Trial Documentation, Medical Writing

Consulting Scientific and Technical Consulting

Product Development Product Evaluation

Work Experience

Regulatory affairs Manger

3V SIGMA

January 1994 - January 2004

Executive Regulatory Affairs

PH&T

September 1992 - April 1994

Clinical Research Associate (phase III studies)

CILAG (JANSSEN GROUP)

January 1990 - July 1992

Education

Master in Pharmacy

Milan University

October 1984 - July 1989

Certifications

• Pharmacology Certification (Ph.D)

  University of Pavia School of Medicine

  January 1990 - Present