Job Description
📋 Description Oversee clinical safety and pharmacovigilance activities across projects. Serve as central resource for safety decision-making and process improvement. Partner with sponsors, vendors, study teams, and internal stakeholders on safety tools and Manage SAE/SUSAR case activities from intake through regulatory reporting. Lead safety database assessment, setup, and ongoing management. Provide training and mentorship to Safety Specialists and team members. 🎯 Requirements Bachelor’s degree in a relevant field. 10+ years of clinical safety experience. 5+ years of pharmacovigilance experience. Hands-on experience with global safety databases, SAE processing, and safety report generation. Strong knowledge of MedDRA and WHODrug coding systems. Working knowledge of FDA safety regulations, ICH guidelines, and global pharmacovigilance 🎁 Benefits Competitive salary: $110,700 – $166,100 USD. Eligibility for discretionary annual bonus opportunities. Comprehensive health insurance, retirement savings, life and disability coverage. Paid time off, parental leave, remote work flexibility. Opportunities to contribute to innovative clinical research programs. Professional growth and development opportunities.
