Senior Patient Safety Medical Director (Hybrid)

MFS Investments; Boston (MA); Hybrid; USD 180,000 - 260,000; Full time

Job summary

Vertex is seeking a Patient Safety Medical Director to provide medical safety expertise for vaccines and therapies, guiding safety activities across product lifecycles. The role focuses on risk management, cross-functional leadership, and ensuring regulatory compliance globally.

The candidate will monitor benefit-risk profiles, chair safety teams, respond to health authority queries, and contribute to safety reporting including DSUR/PSUR/PADER, with opportunity for hybrid/on-site work.

Qualifications

• MD degree or equivalent (e.g., DO or MB) required.
• Typically requires 5 years of experience in Safety/Pharmacovigilance.
• Experience with regulatory agency interactions and safety reporting.

Responsibilities

• Provide medical safety expertise for assigned products across lifecycle.
• Lead safety risk management and chairs Disease-area Safety and Product Safety Teams.
• Develop safety responses to health authority queries and monitor signals.
• Conduct medical evaluation of safety information from trials, toxicology, and quality.
• Contribute to DSUR, PSUR, and PADER reporting and safety strategy.

Skills

Pharmacovigilance

Safety risk management

Regulatory interactions

Clinical safety analysis

DSUR/PSUR review

Education

MD degree

Job description

Vertex is seeking a Patient Safety Medical Director to provide medical safety expertise for vaccines and therapies, guiding safety activities across product lifecycles. The role focuses on risk management, cross-functional leadership, and ensuring regulatory compliance globally.

The candidate will monitor benefit-risk profiles, chair safety teams, respond to health authority queries, and contribute to safety reporting including DSUR/PSUR/PADER, with opportunity for hybrid/on-site work.