Safety & Pharmacovigilance Specialist I

Responsibilities

• Ensure compliance with FDA, WHO, and global regulatory standards for adverse event reporting
• Manage consistent and timely processing of adverse event reports
• Conduct medical evaluations of reported adverse events
• Support clinical research activities for both marketed and investigational drugs, including adverse event reporting and analysis
• Maintain and update toxicity summary tables for investigational agents
• Perform literature reviews and safety data analysis
• Prepare IND safety reports and assist with NDA safety updates, investigator communications, and product labeling
• Review experimental protocols and informed consent documents; contribute to safety-related presentations

Qualifications

• Familiarity with GCP and ICH guidelines; experience in drug development and clinical trials required
• Knowledge of safety databases and MedDRA coding preferred
• Experience leading clinical or cross-functional teams is a plus
• Strong oral, written, presentation, and computer skills
• Minimum of 2 years in academic, pharmaceutical, or biotech settings

Pay

Rate Range: $70,000-$100,000 (dependent on experience)

Schedule

N/A

Benefits

• Comprehensive Benefit Package: Medical/Dental/Vision, 401K, Sick Leave as Required by Law