Director, Pharmacovigilance

Responsibilities

• Oversight of case processing activities and data management quality
• Ensuring compliance with global safety reporting requirements
• Managing relationships with PV vendors and CROs for service quality
• Leading preparation of regulatory documents such as DSURs and IND safety reports
• Collaborating cross-functionally with Clinical Development and Regulatory Affairs

Qualifications

• Advanced degree in health-related field (PharmD, PhD, MD, or MS)
• 10+ years of pharmacovigilance experience in biotech or pharmaceutical industry
• Experience with clinical-stage programs and outsourced PV models
• Knowledge of FDA, EMA, and ICH pharmacovigilance regulations
• Familiarity with safety databases and case processing workflows

Benefits

• Competitive Medical, Dental, and Vision plans
• 401k plan with 100% match up to first 4% deferral
• Generous Paid Time Off policy
• Employee commuter benefits
• Cell phone stipend

Pay

$204,000 – $305,000 annually

Schedule

Remote - US based candidates only, no visa sponsorship available