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.
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 11 compliant materials for submission to US and 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 |
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| Provides uninterrupted (24/7) coverage by qualified personnel |
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| Transfers data electronically according to ICH E2B (M2) |
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Provides medical information services for literature review to detect signals and/or identify trends |
| Prepares periodic safety update reports (PSURs) |
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| Assists in liability claims, causality assessments, and medical evaluations |
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| Reviews and assesses in-house safety data |
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| Reviews labeling modifications (SmPC variations) for consistency with safety data |
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Writes standard operating procedures and working practices related to organization, infrastructure, and workflow for pharmacovigilance activities |
| Prepares and reviews risk/crisis management strategies |
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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 |
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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 |
Carrie Corboy, RPh, PharmD, CCP Executive Director, Global Safety and Pharmacovigilance Dr. Corboy has 14 years experience in global pharmacovigilance accompanied by experience in regulatory affairs and clinical development. She has worked in large and small pharmaceutical company environments as well as contract research organizations. In her various roles, she has lead internal audits and global inspections (e.g., FDA and MHRA), International Periodic Safety Update Report and Periodic Reporting teams, single-case processing teams and cross-company process (e.g., EU Annual Safety Report) and policy development teams. Other experience includes the successful establishment of a Pharmacovigilance center in India and new company integration. Dr. Corboy completed her education with Rutgers University and the University of Sciences in Philadelphia. She is a registered pharmacist with 9 years pharmacy practice experience in the hospital, clinic, and retail settings; holds a certificate in pharmacy immunization; and is a certified consultant pharmacist. |
504 Carnegie Center, Princeton, NJ 08540