Global Safety and Pharmacovigilance

Standing ready. Worldwide.

PharmaNet’s Global Safety and Pharmacovigilance team supports clinical trials and post-marketing safety surveillance. The team comprises skilled professionals who are highly experienced in drug safety, pharmacovigilance, and pharmacoepidemiology and who understand the changing regulatory environment.

Clinical Trials Services

To manage clinical-trial safety, the team provides qualified medical analysis and review of all Serious Adverse Events (SAEs), and creates the necessary 21 CFR Part 11-compliant materials for submission to US and international regulatory authorities and data safety monitoring boards (DSMBs). Services include:

• SAE’s monitoring
• Expedited SAE reports
• SAE safety narratives
• Annual safety reports
• Safety databases
• Interim safety listings
• Risk management strategies

Post-Marketing Services

With regulatory authorities placing an increased emphasis on risk assessment for marketed drugs, companies can no longer rely solely on periodic reports that list adverse events (AEs). Regulatory authorities today expect greater assessment and analysis of AEs, as well as recommendations for increased safety surveillance monitoring to achieve earlier signal detection. To assist companies during post-marketing surveillance, the Global Safety and Pharmacovigilance team:

• Creates customized programs for managing spontaneous AE reporting
• Provides uninterrupted (24/7) coverage by qualified personnel
• Transfers data electronically in compliance with ICH E2B (M2)
• Provides medical information services for literature review to detect signals and/or identify trends
• Prepares periodic safety update reports (PSURs)
• Assists in liability claims, causality assessments, and medical evaluations
• Reviews and assesses in-house safety data
• Reviews labeling modifications (SmPC variations) for consistency with safety data
• Writes standard operating procedures and working practices related to organization, infrastructure, and workflow for pharmacovigilance activities
• Prepares and reviews risk/crisis management strategies
• Analyzes epidemiologic data to determine strategies for signal detection in safety-surveillance studies and to establish registries for continuous safety monitoring
• Conducts workshops and courses on pharmacovigilance requirements
• Designs, reviews, and implements risk-management plans and safety surveillance studies to include cohort, case-control, post-marketing surveys (simplified Phase IV), registries, and database studies