💼 About This Role

You'll lead DSPV Operations for clinical development programs, ensuring compliance with global regulations and timelines. Your work will directly impact ICSR processing and safety data management across trials. This high-visibility role offers the chance to shape PV operations in a dynamic biotech environment.

🎯 What You'll Do

• Lead ICSR collection, processing, reconciliation, and regulatory submission.
• Oversee safety-clinical database reconciliation and vendor performance.
• Support Safety Management Plan development and cross-functional PV processes.
• Prepare and deliver SAE training to investigators, CRAs, and CROs.

📋 Requirements

• 8+ years of PV experience in Biotech, Pharma, or CRO.
• 5 years of vendor oversight experience for PV services.
• Experience with aggregate safety reports (DSUR, PBRER).
• Knowledge of FDA/EMA regulations and ICH guidelines for PV.

✨ Nice to Have

• Degree in Life Sciences, Pharmacy, or Nursing.
• Experience preparing safety data listings and QC.
• Familiarity with safety database configuration and E2B gateways.

🎁 Benefits & Perks

• 🏖️ Unlimited PTO
• 💳 Lifestyle spending account
• 🚆 Commuting reimbursement
• 💼 Competitive benefits package

📨 Hiring Process

Estimated timeline: 2-4 weeks · AI estimate

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