About the role
Description
Clinical Trial & Pharmacovigilance Manager
Location:
Hybrid
Job Type:
Full-Time
Position Overview:
Venesco is seeking an experienced
Clinical Trial & Pharmacovigilance Manager
to oversee clinical trial operations and ensure robust safety surveillance practices.
Requirements
Key Responsibilities: • Manage clinical trial operations from startup through closeout • Oversee adverse event reporting and pharmacovigilance systems • Ensure compliance with ICH-GCP and regulatory requirements • Coordinate DSMB activities and safety reviews • Develop and maintain clinical study documentation • Collaborate with regulatory teams on submissions
Minimum Qualifications:
• Advanced degree in clinical research, life sciences, or related healthcare field • 8+ years of clinical operations and safety experience • Strong knowledge of ICH-GCP and FDA regulations
Preferred Qualifications:
• Experience with Argus or ArisG safety databases • Clinical trial management certification MUST BE A US CITIZEN and US Board certified MD