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Safety Physician – Client Dedicated (EMEA)

Thermo Fisher Scientific · Milan

🇬🇧 English

Job description

About the role

The Safety Physician provides medical and operational oversight for end‑to‑end medical review activities supporting global pharmacovigilance. You will ensure that individual case safety reports (ICSRs) are medically assessed, submission‑ready, and compliant with global regulations.

Key responsibilities

  • Provide medical review and assessment for ICSRs, focusing on high‑interest or priority cases to ensure completeness, medical coherence, and regulatory compliance.
  • Lead supplemental medical review of key cases, delivering consistent clinical interpretation and documentation in the safety database.
  • Conduct targeted offline quality control, identify recurrent issues, perform root‑cause analysis, and implement improvement actions.
  • Lead follow‑up strategies and engage directly with medical affairs, healthcare professionals, and vendors for complex cases.
  • Oversee ICSR coding standards to ensure consistent application across the organization.

Required profile

  • Experience in medical review of individual case safety reports (ICSRs).
  • Familiarity with pharmacovigilance processes and regulatory requirements.
  • Ability to work collaboratively with Benefit‑Risk, Medical Safety teams, and external partners.
  • Strong analytical skills for quality control and root‑cause analysis.

Required skills

    What we offer

    • Opportunity to work on global pharmacovigilance initiatives within a leading scientific company.
    • Access to resources that support career development and scientific impact.

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    Published 3 mesi fa

    33 views · 0 interested

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    Thermo Fisher Scientific

    Milan