Global Pharmacovigilance & Safety Leader

BioSpace; Cambridge (MA); On-site; USD 140,000 - 190,000; Full time

Job summary

Sanofi US seeks a Global Safety Officer to lead pharmacovigilance and risk management across global development and life-cycle safety activities. The role involves directing SMTs and SATs, providing PV expertise to project teams, and collaborating with Health Authorities to ensure safety and regulatory compliance.

Candidates should have an MD degree with board certification and a minimum of three years in international PV or related clinical development fields.

Qualifications

• Excellent clinical judgment and analytical ability.
• Ability to synthesize data from multiple sources and communicate findings clearly.
• Experience in pharmacovigilance and regulatory submissions is required.

Responsibilities

• Provide PV and risk management expertise to internal and external stakeholders.
• Lead cross-functional Safety Management Teams (SMTs) and internal SATs.
• Coordinate safety input for development plans and due diligence activities.
• Manage signal detection, assessment, and proactive safety analysis strategies.
• Ensure high-quality safety sections in submission documents and responses to health authorities.

Skills

Clinical judgment

Data synthesis

Communication

Risk assessment

Leadership

Teamwork

English proficiency

Pressure management

Education

MD degree

Board-Certified/Board-eligible

Job description

Sanofi US seeks a Global Safety Officer to lead pharmacovigilance and risk management across global development and life-cycle safety activities. The role involves directing SMTs and SATs, providing PV expertise to project teams, and collaborating with Health Authorities to ensure safety and regulatory compliance.

Candidates should have an MD degree with board certification and a minimum of three years in international PV or related clinical development fields.