Remote-Eligible: Patient Safety Epidemiology Lead

Vertex Pharmaceuticals Incorporated; Boston (MA); On-site; USD 180,000 - 250,000; Full time

Job summary

Vertex Pharmaceuticals Incorporated seeks a Patient Safety Epidemiology Associate Director to lead safety and regulatory epidemiology activities across lifecycle. You will oversee study design, feasibility assessments, and execution of post-marketing research strategies, communicating results to internal teams and external regulators.

The role requires PhD in epidemiology and about five years in pharma/biotech, CRO, or academia, with strong expertise in pharmacoepidemiology, regulatory filings,

Qualifications

• Specialized knowledge in pharmacoepidemiologic methods and pharmacovigilance regulations.
• Experience designing/implementing epidemiology studies in pharma/biotech.
• Familiarity with regulatory filings (NDA, PSUR) and safety signals.

Responsibilities

• Lead safety risk management, signal detection, and post-marketing regulatory research strategies.
• Research disease-area epidemiology, evaluate data sources, design observational studies and contribute to regulatory filings.
• Communicate epidemiologic strategy to product teams and stakeholders.
• Oversee study design, protocols, execution, and dissemination of results to regulators and scientific communities.
• Contribute to publications and conference abstracts based on study findings.
• Develop epidemiology sections for Risk Management Plans and regulatory documents.
• Lead literature reviews to support safety evaluation and research strategies.
• Lead post-marketing studies and supervise study execution teams.

Skills

Pharmacoepidemiology methods

Pharmacovigilance regulations

Observational study design

Safety signal detection

Regulatory documentation

Education

PhD in epidemiology

Job description

Vertex Pharmaceuticals Incorporated seeks a Patient Safety Epidemiology Associate Director to lead safety and regulatory epidemiology activities across lifecycle. You will oversee study design, feasibility assessments, and execution of post-marketing research strategies, communicating results to internal teams and external regulators.

The role requires PhD in epidemiology and about five years in pharma/biotech, CRO, or academia, with strong expertise in pharmacoepidemiology, regulatory filings,