PharmaNet’s Global Safety and Pharmacovigilance team offers services to support both clinical trials and post-marketing safety surveillance. The team comprises professionals who are highly experienced in drug safety, pharmacovigilance, and pharmacoepidemiology and who understand the changing regulatory environment. The team is led by Jan Willem van der Velden, MD, FFPM, FISPE.

Clinical Trials Services

To manage clinical-trial safety, the team provides qualified medical review of all Serious Adverse Events (SAEs) encountered during a study. From its review of SAEs, the team creates a variety of 21 CFR Part II compliant materials for submission to US international regulatory authorities and data safety monitoring boards (DSMBs):

(Serious) Adverse Events

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 continued 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 for 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 according to 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