Senior Patient Safety Epidemiology Lead - Remote

Vertex Pharmaceuticals; Boston (MA); Hybrid; USD 140,000 - 210,000; Full time

Benefits offered by this job

Remote-eligible

Annual bonus + equity awards

Job summary

Vertex Pharmaceuticals is seeking an Associate Director of Patient Safety Epidemiology to lead safety and regulatory epidemiology activities across its product portfolio. This role entails directing post-marketing research strategies, study design development, and communication of findings to internal teams and regulatory bodies.

Responsibilities include overseeing observational study designs, feasibility assessments, and inclusion of epidemiology in Risk Management Plans and regulatory filings.

Qualifications

• Specialized knowledge in pharmacoepidemiologic methods and regulatory epidemiology.
• Experience designing and implementing epidemiology studies for regulatory submissions.
• Strong communication of complex methods to diverse audiences.

Responsibilities

• Lead safety risk management, signal detection, and post-marketing research strategies.
• Oversee design and implementation of regulatory post-marketing studies from planning to reporting.
• Collaborate with product teams and external stakeholders to communicate epidemiologic findings.

Skills

Epidemiology expertise

Pharmacovigilance

Observational studies design

Regulatory communication

Project management

Cross-functional collaboration

Education

PhD in Epidemiology

Job description

Vertex Pharmaceuticals is seeking an Associate Director of Patient Safety Epidemiology to lead safety and regulatory epidemiology activities across its product portfolio. This role entails directing post-marketing research strategies, study design development, and communication of findings to internal teams and regulatory bodies.

Responsibilities include overseeing observational study designs, feasibility assessments, and inclusion of epidemiology in Risk Management Plans and regulatory filings.