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