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22040, Falls Church, VA
Clinical Trial & Pharmacovigilance Manager

Sonic Summary

Venesco is seeking a Clinical Trial & Pharmacovigilance Manager for a hybrid full-time position.
The role requires an advanced degree in clinical research or a related healthcare field and at least 8 years of clinical operations and safety experience.
Key responsibilities include managing clinical trial operations, overseeing adverse event reporting, and ensuring compliance with regulatory standards.
The preferred qualifications include experience with Argus or ArisG safety databases and a clinical trial management certification.
The salary for this position is competitive and commensurate with experience.

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

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