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
Skills Required
- Advanced degree in clinical research or related healthcare field
- 8+ years of clinical operations and safety experience
- Strong knowledge of ICH-GCP and FDA regulations
- Clinical trial management certification
What We Do
Venesco, LLC is a government contractor providing management consulting, IT, healthcare, research & development, and mission-critical services to federal agencies.
