Medical Director Pharmacovigilance

📋 Description

• Own safety across Apogee's pipeline and data quality.
• Support regulatory approvals and patient safety.
• Provide safety input for lifecycle management.
• Lead DSURs and safety sections of protocols.
• Provide safety input to regulatory submissions (INDs/CTAs).
• Collaborate with Regulatory Affairs and Quality on CAPAs.

🎯 Requirements

• MD degree is required.
• Minimum 8 years of pharmacovigilance experience.
• Strong expertise in global regulatory requirements (FDA, EMA, MHRA, PMDA, ICH).
• Experience with biologics and dermatology/respiratory indications a plus.
• Experience in late-stage development and submissions.
• Travel up to 20%.

🎁 Benefits

• Great culture grounded in CORE values.
• Fast-paced environment with multiple hats.
• Market-competitive compensation with base, bonus, and equity.
• Generous time off: 3 weeks PTO, two shutdown weeks, sick leave.
• Professional growth opportunities and resources.
• Regular all-team in-person meetings to build relationships.