Senior Medical Safety Specialist

Job Summary

Providing medical expertise and assessment to support patient safety throughout the product lifecycle, the full-time remote Senior Medical Safety Specialist will evaluate safety signals, author assessments, and collaborate with cross-functional teams to enhance patient safety practices.

Key responsibilities

• Evaluate events and safety signals, authoring high-quality safety assessments based on various data sources
• Provide evidence-based medical safety input and responses to inquiries from internal and external stakeholders
• Maintain proficient knowledge of assigned products and therapies, and develop solutions to improve safety practices

Required qualifications

• 4+ years of clinical experience (2+ years with an advanced degree)
• Active healthcare license with clinical knowledge and relevant patient care experience
• Bachelor's degree or higher in a biologic science or related medical/scientific field
• Solid understanding of regulatory guidance from FDA and EMEA
• Proficient in Microsoft Office applications, including Word and Excel