Senior Director, Pharmacovigilance (Safety Science & Surveillance)

📋 Description

• Lead Safety Sciences/Surveillance; set strategies for signal detection, risk management, and aggregate reporting.
• Guide safety strategy for regulatory submissions and lifecycle management.
• Serve as safety lead on cross-functional governance committees (e.g., Safety Monitoring Committees).
• Develop and evolve safety signal detection methodologies and signaling strategies.
• Oversee risk management plans (RMPs/REMS) and other risk minimization activities.
• Ensure inspection readiness and interactions with global regulatory authorities.

🎯 Requirements

• PharmD or PhD in life sciences preferred.
• 12+ years of experience in pharmacovigilance or drug safety.
• 5+ years in leadership roles within Safety Sciences, Signal Detection, or Safety Surveillance.
• Strong background in oncology; experience in clinical development and post-marketing safety.
• Experience supporting global regulatory submissions and health authority interactions.
• Strong knowledge of signal detection methodologies and benefit-risk assessment.

🎁 Benefits

• Competitive compensation package with equity and annual bonus.
• 401K with employer contributions and stock options.
• Generous benefits package with health, dental, vision; ESPP.
• PTO 20 days; 18 holidays; paid parental leave.
• Lifestyle stipend, commuter stipend (Boston), and flexible options.
• In-office catered lunches and home office setup.