💼 About This Role

You'll manage vendor oversight and ICSR processing for investigational products in a clinical-stage biotech company. You'll ensure regulatory compliance and data integrity across Phase 1-3 studies. This role offers direct impact on safety operations strategy.

🎯 What You'll Do

• Manage relationship with safety vendors for outsourced activities
• Oversee case workflow from receipt to submission
• Participate in operational safety tasks for clinical programs
• Develop and maintain SOPs for regulatory compliance

📋 Requirements

• Bachelor's degree in Nursing, Pharmacy, or related health field
• 8-10 years of drug safety experience in biotech/pharma
• Experience with ICSR case-processing and safety databases
• Knowledge of FDA/EMA/ICH regulatory requirements

✨ Nice to Have

• Direct experience managing external service providers
• Knowledge of MedDRA coding
• Clinical development experience

🎁 Benefits & Perks

• 🩺 Medical, dental, and vision insurance
• 💰 401(k) retirement savings plan
• 🏖️ Generous paid time off including company shutdowns

📨 Hiring Process

Estimated timeline: 3-5 weeks · AI estimate

1. 1Recruiter Screen· 30 min
2. 2Hiring Manager Interview· 45 min
3. 3Panel Interview· 60 min