💼 About This Role

You'll lead safety surveillance activities for CNS drug programs, including medical review of case reports and signal detection. Your work will ensure proactive compliance with global regulations and support regulatory submissions. This role offers the opportunity to shape safety risk management across the product lifecycle.

🎯 What You'll Do

• Manage safety surveillance and signal detection activities.
• Represent Pharmacovigilance at clinical study team meetings.
• Develop signal assessment reports for validated safety signals.
• Collaborate with PV operations for medical review of ICSRs.
• Develop and manage periodic reports (DSUR/PBRER).

📋 Requirements

• Health care professional degree (RN, BSN, PharmD) or advanced degree (Masters/PhD) in biomedical sciences.
• Minimum of 10 years pharmacovigilance experience in biopharmaceutical industry.
• Experience with MedDRA and drug coding reviews.
• Demonstrated expertise in global PV regulations, GVP and ICH guidelines.

✨ Nice to Have

• Post-graduate training in epidemiology (e.g., MPH).
• Safety surveillance experience in neuroscience or psychiatry.
• At least 3 years of direct clinical/patient care experience.

🎁 Benefits & Perks

• 💰 Annual bonus opportunity
• 🏥 Medical, dental, vision, life and AD&D insurance
• 🏖️ Flexible non-accrual paid time off
• 👶 Parental leave
• 📈 401(K) plan with match and stock options

📨 Hiring Process

Estimated timeline: 2-4 weeks · AI estimate

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