Clinical Trial & Pharmacovigilance Manager

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