Associate Manager of Compliance

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

May 15, 2025 - 21:56
 0
Associate Manager of Compliance
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