Clinical Trial & Pharmacovigilance Manager
VENESCO, LLC•Falls Church, VA
•Hybrid
About The Position
We are seeking an experienced Clinical Trial & Pharmacovigilance Manager to oversee clinical studies and ensure robust safety surveillance.
Requirements
- 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
Nice To Haves
- Experience with safety databases (Argus, ArisG)
- Clinical trial management certification
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
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What This Job Offers
Job Type
Full-time
Career Level
Senior
