Executive And Global Gcp/Gvp Consultant
CurrentClinical and Pharmacovigilance Quality Assurance and Quality Compliance professional with 25+ years dedicated to global clinical and pharmacovigilance quality and compliance system and auditing oversight at leading pharmaceutical companies, including Johnson & Johnson, Sanofi Aventis, and Merck. Knowledge of GCP/GVP PV, FDA 21 CFR guidances, EMA, EU directives, ICH guidances, GVP Modules, GDP practices, and other regulatory requirements.Good Clinical Practice (GCP) and Good Pharmacovigilance (GVP) quality & compliance audits of Phase I – Phase IV, consumer and medical device at investigator sites, sponsor regional/country offices, quality systems, medical/clinical operations, clinical trial mgmt. systems, drug safety systems, regulatory submissions, labeling, marketing partners, vendors/suppliers.Manage international health authority (HA) inspections (e.g., BIMO, FDA, EMA) including pre-inspection preparation, on-site front/back room support, post-inspection management and response to inspection observations and CAPAs management, issue escalation, Regulatory Affairs submissions, project management, Risk Identification and Risk Mitigation.Support pharma, medical device and consumer across several therapeutic areas. Overview of Expert Knowledge and Experience:• Clinical and Pharmacovigilance audits and HA inspection support• CAPA management• GCP/PV, FDA, EMA, ICH regulatory requirements• Product Quality Complaints and Non-Conformance• Pharmaceutical / Device Safety Oversight• Risk identification, management and mitigation• Clinical Trial Site Monitor• Clinical Trial Finance Manager• Clinical Data Coordination• Adverse Events (AE/SAE) & Medical Device Reporting (MDR)• MSc Regulatory Science• Health Care Compliance certification• BA Economics & Management Sciences• Society for Quality Assurance certification• Medical Laboratory Technology certification, MDSAP Certification* Greater New York / Northern, NJ (Available to travel globally)
