Senior Director, Drug Safety and Pharmacovigilance

📋 Description

• Maintain post-market and clinical PV data systems for ICSR handling
• Oversee safety contract service organizations (CSOs) for PV programs
• Develop safety analyses for internal leadership and regulators
• Manage global PV data systems and inspection readiness
• Lead regulatory submissions for PSUR, PBRER, and RMP
• Drive safety programs to meet company goals and KPIs

🎯 Requirements

• Requires at least 12 years in drug safety and pharmacovigilance
• Bachelor's degree in healthcare or equivalent; advanced degree preferred
• Experience with PV systems Argus, ArisG, VeevaSafety
• Regulatory submissions for PSUR, PBRER, RMP; US/EU/Canada/Brazil/Australia preferred
• Ability to manage PV contract service organizations and inspections
• Strong leadership, collaboration, and communication skills; willingness to travel

🎁 Benefits

• Market-leading compensation
• 401(k) with employer match
• 100% employer-paid medical, dental, and vision for you and dependents
• Fertility and family-forming benefits
• ESPP (Employee Stock Purchase Program)
• Hybrid work model with flexible PTO and holidays