Clinical Research Company

For a clinical research company, RHO medical writers were responsible for Drug Safety Reporting.

Responsibilities also included preparation of scientific presentations, slide presentations, NDA documents, clinical study reports, clinical study protocols, periodic safety update reports, drug information letters, labeling documents, and other procedures to support pharmacovigilance activities. RHO team researched literature and appropriate data sources to understand nature of adverse drug reactions and reported on potential adverse events Clinical assessments were conducted and information was processed on reported serious adverse drug and device experiences (ADEs) in the safety database. Reports were checked for completeness, accuracy and consistency of information to maintain regulatory compliance.

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