Safety Scientist

Job Summary

To support scientific operations, the remote Safety Scientist will design and analyze clinical trials, interpret complex medical data, and collaborate with physicians and scientists on safety management activities.

Key responsibilities

• Support the coordination and preparation of Safety Management Team meetings
• Assist in the preparation of Development Safety Update Reports (DSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), and other safety-related documentation
• Contribute to internal safety process improvements and prepare for regulatory inspections and audits

Required qualifications

• Healthcare degree (e.g., BSN, CRNP, Pharm.D.) or relevant scientific degree with industry experience preferred
• Two to four years of Pharmacovigilance/Drug Safety experience required
• Experience analyzing safety case reports and preparing aggregate safety reports
• Fluency in written and spoken English
• Experience in pharmaceutical industry activities involving health authorities in the U.S. and Europe