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
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