Senior Medical Affairs Safety Associate

Why consider this job opportunity

Employer Industry: Healthcare and Medical Devices

Salary up to $194,000

Competitive compensation package with benefits and equity program

Opportunity to be part of a team revolutionizing treatments for serious diseases

Generous benefits package including medical, dental, vision, life insurance, and 401(k) with employer match

Collaborative work environment focused on continuous learning and performance rewards

Minimum of fifteen days of accrued vacation per year, increasing with tenure

• Monitor participant safety throughout clinical studies by reviewing adverse events (AEs) and serious adverse events (SEAs)
• Evaluate events for unanticipated adverse device effects per FDA and ICH‑GCP guidelines
• Report adverse events to regulatory agencies as required by country‑specific regulations
• Participate in Clinical Trial Team meetings, providing safety updates and addressing safety issues
• Develop safety plans and appropriate charters for studies

• Bachelor’s degree in Public Health, Nursing, Medicine, or related discipline with 6+ years of experience in medical monitoring or clinical research
• Minimum of 2+ years of medical device and safety operations experience
• Familiarity with electronic data capture (EDC) systems and imaging platforms
• Knowledge of ICH‑GCP, FDA, and EU regulations
• Excellent verbal and written communication skills

• Experience with MedDRA coding and SAE adjudication processes
• High level of competency with Microsoft Office applications, including Word & Excel
• Strong organization, communication, and stakeholder management skills
• Excellent attention to detail and problem-solving skills