Clinical Safety Director

New

Skills

Clinical Trial Protocols EMA Regulations FDA Regulations Global Safety Reporting MedDRA Coding Medical Safety Assessment Pharmacovigilance SAE Narratives Safety Vendor Management Signal Detection

As a Senior Medical Director in Clinical Safety at BlueRock, you will be the medical safety lead for our clinical trial portfolio. This role is crucial in ensuring the safety and efficacy of our innovative treatments, particularly in the realm of cell and gene therapy.

Key Responsibilities
  • Lead SAE/SUSAR assessments and causality determinations.
  • Own safety signal detection and aggregate safety reviews.
  • Prepare safety sections for protocols, SAPs, CSRs, and DSURs.
  • Oversee safety vendor selection and pharmacovigilance operations.
  • Ensure global safety reporting compliance and readiness for inspections.
Required Skills & Qualifications
  • MD (or equivalent) required; active clinical training valued.
  • 5+ years of experience in pharma/biotech drug safety and pharmacovigilance.
  • Strong knowledge of FDA/EMA safety regulations and familiarity with ICH E2.
  • Hands-on experience with SAE narratives and MedDRA coding.
  • Excellent communication skills and a builder mindset in a lean, matrixed environment.

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Job Type: Remote

Salary: Not Disclosed

Experience: Entry

Duration: Months

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