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Author: Umsebenzi Remote JOBS
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
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