Safety Reporting Associate

A company is looking for a Safety Reporting Associate responsible for managing individual case safety reports and periodic safety reports. Key Responsibilities Ensure timely and compliant submission of individual case reports and periodic safety reports Oversee all aspects of pharmacovigilance safety reporting and participate in project teams Maintain knowledge of global regulations and assist in audits and inspections related to safety reporting Required Qualifications Bachelor's degree or equivalent formal academic/vocational education 2+ years of relevant experience in safety report distribution and submission Strong understanding of Good Clinical Practices (GCPs) and global safety reporting regulations In-depth knowledge of pharmacovigilance regulations and medical terminology Proficiency in Microsoft Office and relevant safety database applications

Apr 8, 2025 - 23:55

A company is looking for a Safety Reporting Associate responsible for managing individual case safety reports and periodic safety reports. Key Responsibilities Ensure timely and compliant submission of individual case reports and periodic safety reports Oversee all aspects of pharmacovigilance safety reporting and participate in project teams Maintain knowledge of global regulations and assist in audits and inspections related to safety reporting Required Qualifications Bachelor's degree or equivalent formal academic/vocational education 2+ years of relevant experience in safety report distribution and submission Strong understanding of Good Clinical Practices (GCPs) and global safety reporting regulations In-depth knowledge of pharmacovigilance regulations and medical terminology Proficiency in Microsoft Office and relevant safety database applications