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Safety Physician

Granite Bio · Bâle

Junior 🇬🇧 English
Pharmacovigilance MedDRA GCP SOPs DSUR Statistical analysis plan

Job description

About the role

GRANITE BIO is seeking a Safety Physician to lead medical monitoring and pharmacovigilance activities for its early‑stage immunology and inflammation programs. The role combines safety oversight, data review, and collaboration with cross‑functional teams to ensure rigorous clinical development.

Key responsibilities

  • Perform medical monitoring and pharmacovigilance, including eligibility checks and safety data review.
  • Provide causality assessments and review MedDRA coding activities.
  • Conduct safety review of clinical and diagnostic data and generate aggregate reports (e.g., DSUR).
  • Assist in creating project‑specific medical review procedures.
  • Contribute to design, execution, and reporting of Phase 1/2 trials in the I&I space.
  • Support medical team strategy and ensure data generation follows GCP/SOPs.
  • Collaborate with Clinical Operations and Biomarker teams to meet study milestones.
  • Help develop statistical analysis plans and author clinical documents such as protocols and safety management plans.

Required profile

  • Advanced medical degree (MD).
  • Minimum 1 year experience in clinical research or development within pharma/biotech, preferably early‑phase trials.
  • Proven ability to work collaboratively with physicians, consultants, and vendors.
  • Strong analytical mindset with excellent written and verbal communication.
  • Exceptional attention to detail, organizational skills, and sound judgment.

Required skills

  • Pharmacovigilance and medical monitoring.
  • MedDRA coding.
  • Good Clinical Practice (GCP) compliance.
  • Standard Operating Procedures (SOPs) implementation.
  • DSUR preparation.
  • Statistical analysis plan development.

What we offer

  • Dynamic, interdisciplinary environment in a fast‑growing biotech.
  • Work‑from‑home flexibility according to internal workflows.
  • Opportunity to contribute to first‑in‑class therapeutic programs.

Questions fréquentes

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Published 2 months ago

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Granite Bio

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