Clinical Safety Analyst - Remote

Overview

The Clinical Safety Analyst will be responsible for triaging incoming Serious Adverse Event (SAE) information, participating in safety surveillance activities, and ensuring compliance with regulatory requirements.

In Short

• Triages incoming SAE information for timely reporting.
• Participates in safety surveillance activities for assigned products.
• Collects, analyzes, and triages Adverse Events.
• Conducts medical review of safety-related data.
• Interfaces with study managers and clinical research organizations.
• Creates narratives of serious adverse events.
• Responsible for clinical safety capture and reporting.
• Identifies safety data needs and ensures data completeness.
• Adheres to policies and regulations.
• Must be proficient in computer applications.

Requirements

• Bachelor's degree in health science preferred.
• 2 years of clinical experience required.
• Understanding of ICH/FDA regulations.
• Knowledge of product labeling and safety profile.
• Able to apply clinical knowledge to data collection.
• Competent in presenting data orally and in writing.
• Adheres to policies and regulations.
• Computer proficiency in Windows, Word, Excel.

Benefits

• Equal opportunity employer.
• Commitment to innovation and community service.
• Potential for career growth and development.