Senior Director, Patient Safety & Risk Management

Vertex Pharmaceuticals; Boston (MA); Hybrid; USD 276,000 - 414,000; Full time

Benefits offered by this job

Total Rewards package

Hybrid/On-site work options

Education assistance and student loan"

Job summary

Vertex Pharmaceuticals seeks a Senior Medical Director, Patient Safety, DAS Head to lead safety and benefit-risk activities across disease areas, from first-in-human trials through commercialization. You will ensure consistent safety assessment, analysis and reporting in global markets, directly or through reports, and guide pre-marketing risk assessment and REMS/RMP planning.

The role partners with Clinical Teams, Medical Affairs, and Partners to proactively manage safety issues, with a focus

Qualifications

• Doctorate in Medicine (M.D.) required; pharmacovigilance experience is a plus.
• Strong leadership and collaboration across matrix teams.
• Deep knowledge of global safety regulations and risk management.

Responsibilities

• Provide leadership and oversight of safety strategy for designated products.
• Coordinate safety signal detection and risk management planning.
• Collaborate with Clinical, Medical Affairs and Regulatory teams on safety content for submissions.
• Review safety data and provide medical input for labeling and regulatory responses.
• Mentor and develop staff within the safety organization.

Skills

Leadership

GCP & Regulations

Data interpretation

Communication

Strategic planning

Pharmacovigilance

Education

Doctorate in Medicine (M.D.)

Job description

Vertex Pharmaceuticals seeks a Senior Medical Director, Patient Safety, DAS Head to lead safety and benefit-risk activities across disease areas, from first-in-human trials through commercialization. You will ensure consistent safety assessment, analysis and reporting in global markets, directly or through reports, and guide pre-marketing risk assessment and REMS/RMP planning.

The role partners with Clinical Teams, Medical Affairs, and Partners to proactively manage safety issues, with a focus