Safety Specialist II

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Requirements:

• 4-year college degree in Pharmacy, Nursing, or a scientific or healthcare discipline.
• 3-5 years of clinical trial, pharmacovigilance, or drug safety experience.
• Advanced knowledge of the organization and structure of clinical studies.
• Good understanding of technical and content knowledge.
• Solid knowledge of FDA safety regulations, EMA, and other global safety regulations.
• Experience with global safety databases and SAE case processing.

Responsibilities:

• Intake, triage, processing, evaluation, and reporting of incoming Serious Adverse Event (SAE) reports.
• Serve as primary safety specialist on complex studies.
• Provide guidance on Pharmacovigilance best practices.
• Interface with sponsors and vendors for drug safety processes.
• Participate in the set-up of safety databases.
• Perform data entry, medical coding, and narrative writing for individual case safety reports.
• Prepare and review project-specific safety reporting plans and training materials.
• Mentor or train new staff and support department development initiatives.