Safety Science Coordinator I - Remote

Overview

The Safety Science Coordinator I will assist with the overall Clinical Safety and/or PSS operations associated with products, including managing adverse events processes and ensuring compliance with safety standards and regulations.

In Short

• Assist in processing Expedited Safety Reports (ESRs) and Periodic Safety Reports (PSRs).
• Maintain adverse event tracking systems and project files.
• Log incoming Adverse Event (AE) reports into tracking applications.
• Generate queries for missing or discrepant information.
• Ensure compliance with regulatory requirements and quality standards.
• Provide administrative support to PSS personnel.
• Train and mentor PSS Assistants or peers.
• Build and maintain good relationships across functional units.
• Prepare safety study files for archiving upon project completion.
• Handle multiple tasks with attention to detail.

Requirements

• Non-Degree or 1-2 years of Safety experience or relevant experience.
• Associate degree or 6 months to 1 year of Safety experience.
• BS/BA with 0-6 months to 1 year of Safety experience.
• MS/MA with 0-6 months of Safety experience.
• PharmD with 0-6 months of Safety experience.
• Good team player with strong communication skills.
• Ability to set priorities and handle multiple tasks.
• Good written and verbal communication skills.
• Knowledge of MS Office and Windows is beneficial.
• Attention to detail and logical skills.

Benefits

• Opportunity to work in a dynamic environment.
• Support for career growth and development.
• Collaborative team culture.
• Work-life balance initiatives.
• Access to resources for continued learning.