Remote Patient Safety Epidemiology Leader

Vertex Pharmaceuticals Inc (US)

United States

Hybrid

USD 163,000 - 245,000

Full time

14 days+
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Benefits offered by this job

Annual bonus
Equity awards

Job summary

Vertex Pharmaceuticals Inc (US) is seeking a Patient Safety Epidemiology Associate Director to lead safety and regulatory epidemiology activities across products and lifecycle.

You will oversee post-marketing regulatory study strategies, feasibility assessments, and development of observational study designs, coordinating study implementation and communicating findings to internal and external stakeholders.

Qualifications

  • PhD in epidemiology is required.
  • Typically requires 5+ years of pharma/biotech/CRO/academic experience.
  • Ability to design and interpret pharmacoepidemiology studies and communicate results clearly.

Responsibilities

  • Lead safety and regulatory epidemiology activities for Vertex products.
  • Oversee post-marketing regulatory study strategies and regulatory filings (NDA, PSUR).
  • Coordinate observational study designs, feasibility assessments and study implementation.
  • Communicate findings to internal teams and external stakeholders such as regulators and scientific communities.
  • Mentor interns/contractors where applicable.

Skills

Pharmacoepidemiology
Pharmacovigilance
Study design
Regulatory communication
Leadership

Education

PhD in epidemiology

Job description

Vertex Pharmaceuticals Inc (US) is seeking a Patient Safety Epidemiology Associate Director to lead safety and regulatory epidemiology activities across products and lifecycle.

You will oversee post-marketing regulatory study strategies, feasibility assessments, and development of observational study designs, coordinating study implementation and communicating findings to internal and external stakeholders.

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