Associate Manager of Compliance

Job Summary

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

Key Responsibilities

• Manage adverse event handling and reporting for Pharmacovigilance (PVRM) and non-PVRM vendors
• Oversee training management, ensuring compliance with corporate policies and regulations
• Participate in audit and inspection preparedness, supporting regulatory inspections and internal audits

Required Qualifications

• Bachelor's degree in a scientific, regulatory, or health-related field
• 2 - 3 years of relevant experience in biotech or pharmaceutical industry, specifically in Pharmacovigilance operations and compliance
• Strong understanding of FDA and Health Canada regulations
• Proficient in end-to-end case management of clinical trial and post-market ICSRs
• Experience with ARGUS, MedDRA, WHODD, MS Office Suite, SharePoint, and Veeva systems