Manager Compliance Training

Job Summary

A company is looking for a Manager, Compliance, Training & Strategic Alliance (CTSA), PVRM.

Key Responsibilities:

• Manage PVRM and non-PVRM vendors, oversee adverse event handling and reporting, support global PV system
• Liaise with internal and external stakeholders, manage compliance, document storage, and archiving activities
• Contribute to audit and inspection preparedness, conduct routine AE case quality checks, and support ad-hoc projects

Required Qualifications:

• Bachelor's degree in a scientific, regulatory, or health-related field
• 6-8 years of relevant experience in the healthcare industry
• 3 years of specific experience in Pharmacovigilance operations and compliance
• Strong understanding of U.S. regulations and guidance, knowledge of global regulations
• Fundamental working knowledge of European Economic Area, United Kingdom, and Canadian regulatory frameworks