Safety & Pharmacovigilance Specialist I - 173066

Responsibilities: of the Safety & Pharmacovigilance Specialist I include: · 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: for the Safety & Pharmacovigilance Specialist I include: · 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 Compensation: for Safety & Pharmacovigilance Specialist I includes: · Rate Range: $70,000-$100,00+ (dependent on experience) · Comprehensive Benefit Package: Medical/Dental/Vision, 401K, Sick Leave as Required by Law This job is open for applications on August 27th, 2026. Applications will be accepted at least 30 days from the posting date.