Clinical Trial & Pharmacovigilance Manager

Venesco, LLC; Falls Church (VA); Hybrid; USD 100,000 - 140,000; Full time

Job summary

Venesco, LLC is looking for a Clinical Trial & Pharmacovigilance Manager to manage clinical trial operations and ensure compliance with safety regulations.

The ideal candidate has an advanced degree in clinical research, over 8 years of related experience, and strong knowledge of ICH-GCP and FDA regulations. The position is hybrid and requires US citizenship and board certification.

Qualifications

• 8+ years of clinical operations and safety experience required.
• Strong knowledge of ICH-GCP and FDA regulations essential.
• Must be a US citizen and a US Board certified MD.

Responsibilities

• Manage clinical trial operations from startup through closeout.
• Oversee adverse event reporting and pharmacovigilance systems.
• Ensure compliance with ICH-GCP and regulatory requirements.

Skills

Clinical operations management

Pharmacovigilance systems

Regulatory compliance

Education

Advanced degree in clinical research or life sciences

Tools

Argus or ArisG safety databases

Job 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.

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