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DEDebiopharm

Associate Safety Physician(m/w/x)

Lausanne
Full-timeOn-siteExperienced

Managing product safety data and medical reviews for cancer/infectious disease treatments. MD with 2-3 years clinical/pharma experience required. Equal-Pay certified workplace.

Requirements

  • MD with 2-3 years clinical/pharma experience or Physician with research fellowship
  • Proven ability in medical review, data analysis, safety surveillance
  • Solid understanding of GCP and PV principles
  • Excellent English verbal and medical writing skills
  • Thrive in high-stress matrix environment, collaborate effectively
  • Strong problem-solving skills, meet deadlines, maintain quality
  • Master's Degree
  • Associate level experience

Tasks

  • Manage and evaluate product safety data
  • Manage project safety profiles
  • Conduct individual and aggregate medical reviews
  • Provide medical input for study protocols
  • Provide medical input for Investigator Brochures
  • Provide medical input for Development Safety Update Reports
  • Lead ongoing safety monitoring
  • Lead signal detection
  • Partner with Clinical teams
  • Partner with Regulatory teams
  • Partner with Biostatistics teams
  • Represent Safety in study teams
  • Represent Safety in internal task forces
  • Represent Safety in external meetings
  • Contribute to safety sections of IND/NDA submissions
  • Maintain inspection readiness for audits
  • Maintain inspection readiness for inspections

Work Experience

  • 2 - 3 years

Education

  • Vocational certificationOR
  • Bachelor's degreeOR
  • Master's degree

Languages

  • EnglishBusiness Fluent

Benefits

Informal Culture

  • Inclusive and respectful workplace

Competitive Pay

  • Equal-Pay certified
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