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Clinical Trial & Pharmacovigilance Manager
VENESCO LLC · Falls Church, VA
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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