Vice President, Drug Safety & Pharmacovigilance - Remote

Overview

The Vice President of Drug Safety & Pharmacovigilance will lead global safety and pharmacovigilance efforts across all development programs, ensuring patient safety and regulatory compliance.

In Short

• Lead global safety and pharmacovigilance strategy.
• Collaborate with Clinical, Regulatory, Medical Affairs, and Quality teams.
• Drive benefit-risk assessments and regulatory authority interactions.
• Oversee signal detection using various data sources.
• Ensure global PV compliance and readiness for inspections.
• Manage vendor relationships and safety database operations.
• Submit safety reports to regulatory bodies.
• Build and lead a high-performing internal safety team.
• 10+ years in pharmacovigilance and drug safety required.
• Experience in a small company environment preferred.

Requirements

• MD or equivalent required.
• 10+ years in pharmacovigilance and drug safety.
• Autoimmune experience preferred.
• Expert in MedDRA and signal detection methodologies.
• Familiarity with 21 CFR regulations.
• Skilled in regulatory engagement and negotiation.
• Proven leadership abilities.
• Ability to manage teams and vendors effectively.
• Practical, risk-based decision maker.
• Bias for action and urgency in execution.

Benefits

• Competitive salary and benefits.
• Opportunity to lead a critical function in a growing company.
• Collaborative work environment.
• Impactful role in patient safety.
• Professional growth and development opportunities.