💼 About This Role

You'll lead medical assessment of safety data for novel cancer therapies, collaborating with cross-functional teams to ensure regulatory compliance and patient safety. You'll shape safety surveillance strategies and contribute to regulatory submissions. This role offers the chance to impact early-stage drug development at a highly innovative biotech.

🎯 What You'll Do

• Provide medical expertise in assessing individual case safety reports (ICSRs)
• Contribute to aggregate safety reports like DSURs and PSURs
• Lead safety signal detection and evaluation
• Support development of Risk Management Plans (RMPs/REMS)

📋 Requirements

• 4+ years of drug safety/pharmacovigilance experience in biotech/pharma
• Medical degree (MD) from recognized medical school preferred
• In-depth knowledge of US and EU drug safety regulations and ICH guidelines
• Experience with medical review of ICSRs including causality assessments and narrative generation

✨ Nice to Have

• Experience with IND/NDA submissions and regulatory negotiations
• Experience developing Reference Safety Information (IB, CCDS, labels)
• Familiarity with MedDRA coding and SMQs

🎁 Benefits & Perks

• 💰 Competitive salary with annual range $210k-$235k
• 🏥 Medical, dental, and vision insurance
• 🏖️ Generous PTO including summer and winter company shutdown
• 📈 401(k) retirement savings plan

📨 Hiring Process

Estimated timeline: 2-4 weeks · AI estimate

1. 1Recruiter Screen· 30 min
2. 2Hiring Manager Interview· 45 min
3. 3Technical/Case Interview· 60 min