Global Director, Patient Safety & Risk Management

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

Benefits offered by this job

Total Rewards package

Medical/Dental/Vision benefits

Commuting subsidy

401(k) and equity awards

Job summary

Vertex Pharmaceuticals Incorporated in Boston seeks a Senior Medical Director, Patient Safety, Disease Area Safety Head to lead safety and benefit-risk activities from early trials through commercialization.

You will partner with GPS leadership, clinical teams, and regulatory affairs to oversee risk management plans, safety content in regulatory submissions, and post-marketing safety reporting, while mentoring staff.

Qualifications

• MD required; typically 7 years of work experience with pharmacovigilance and 5 years of supervisory/management experience.

Responsibilities

• Provides leadership and oversight of Safety Team(s) for products within assigned therapeutic area(s).
• Coordinates and oversees safety signals detection.
• Collaborates with Clinical Leaders on Risk Management procedures/plans.
• Leads development of SCS, CLO, Label and Risk Management Plans for submissions.
• Reviews safety data and contributes to regulatory inquiries.

Skills

General Medicine

GCP/ICH/global regulations

Leadership

Data interpretation

Benefit-Risk strategies

Multi-tasking

Education

Doctorate in Medicine (M.D.)

Tools

Regulatory submissions

Job description

Vertex Pharmaceuticals Incorporated in Boston seeks a Senior Medical Director, Patient Safety, Disease Area Safety Head to lead safety and benefit-risk activities from early trials through commercialization.

You will partner with GPS leadership, clinical teams, and regulatory affairs to oversee risk management plans, safety content in regulatory submissions, and post-marketing safety reporting, while mentoring staff.