Patient Safety Medical Director — Pharmacovigilance Leader

Vertex Pharmaceuticals Inc (US); Boston (MA); Hybrid; USD 200,000 - 320,000; Full time

Job summary

Vertex Pharmaceuticals Inc. is seeking a Patient Safety Medical Director to provide medical safety expertise for assigned products across the product life cycle, from pre- to post-approval.

The role will optimize patient safety and ensure compliance with global pharmacovigilance regulations through timely safety activities. The position involves leading safety and risk management processes, chairing Safety Teams, and developing responses to health authority queries.

Qualifications

• MD degree or equivalent required.
• Typically requires 5 years of experience in Safety/Pharmacovigilance.
• Experience with Regulatory Agency interactions is expected.

Responsibilities

• Provide medical safety expertise for assigned products across pre- and post-approval.
• Lead safety and risk management processes and chair Disease-area Safety Teams.
• Develop safety responses to queries from health authorities.
• Oversee safety data reviews from trials, literature, and reports.
• Contribute to DSUR/PSUR/PADER and regulatory submissions.

Skills

Pharmacovigilance

Safety risk management

Clinical safety

Data analysis

Regulatory interactions

Leadership

Medical safety leadership

Education

MD degree

Job description

Vertex Pharmaceuticals Inc. is seeking a Patient Safety Medical Director to provide medical safety expertise for assigned products across the product life cycle, from pre- to post-approval.

The role will optimize patient safety and ensure compliance with global pharmacovigilance regulations through timely safety activities. The position involves leading safety and risk management processes, chairing Safety Teams, and developing responses to health authority queries.