Clinical Trial & Pharmacovigilance Manager Job at Venesco LLC, Falls Church, VA

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  • Venesco LLC
  • Falls Church, VA

Job Description

Clinical Trial & Pharmacovigilance Manager

Location: Hybrid
Job Type: Full-Time

About the Role

We are seeking an experienced Clinical Trial & Pharmacovigilance Manager to oversee clinical studies and ensure robust safety surveillance.

Requirements

Key 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

Qualifications

  • 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

Preferred

  • Experience with safety databases (Argus, ArisG)
  • Clinical trial management certification

Job Tags

Full time

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