Jim Halsey
Senior Director, Clinical Qualty Assurance @Alumis
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WORK HISTORY
Senior Director, Clinical Qualty Assurance @Alumis
South San Francisco, CA, US
EDUCATION
The College of New Jersey
Bachelor of Arts - BA
ABOUT JIM HALSEY
Over 20 years of experience in the pharmaceutical industry with extensive expertise in quality assurance services. Experience includes- Management of PV & GCP Audit Programs- International Pharmacovigilance and GCP auditor, conducting audits in over 25 countries - Pharmacovigilance Risk Planning Lead- REMS Regulatory Compliance Management- FDA, MHRA, and Health Canada PV and GCP Inspections- Development of Quality Management Systems - Conducting audits of Company Affiliates, Contract Research Organizations (CROs), Phase I Units, Clinical Databases, Central Files - Highly experienced in PV/GCP Internal Systems audits including REMS, Signal Management, Literature Review, Aggregate Reporting, Single Case Management, Epidemiology, Product Complaints, Data Management, Trial Master File, Clinical Supply Operations, Controlled Substance Handling, and Serious Adverse Event (SAE) Reconciliation.
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