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Job Description
Clinical Trial & Pharmacovigilance Manager
VENESCO, LLC - 3.3
Falls Church, VA Job Details Full-time 23 hours ago Qualifications ICH guidelines Clinical research compliance Research regulatory compliance FDA regulations
Full-Time About the Role We are seeking an experienced Clinical Trial & Pharmacovigilance Manager to oversee clinical studies and ensure robust safety surveillance.
Requirements:
Key Responsibilities Manage clinical trial operations from startup to closeout Oversee adverse event reporting and pharmacovigilance systems Ensure compliance with GCP and regulatory requirements Coordinate DSMB activities and safety reviews Develop and manage clinical study documentation Collaborate with regulatory teams on submissions Qualifications Advanced degree in clinical research, life sciences, or healthcare field 8+ years of clinical operations and safety experience Strong knowledge of ICH-GCP and FDA regulations Preferred Experience with safety databases (Argus, ArisG) Clinical trial management certification