Clinical Safety Analyst (Clinical Trial Safety)

Location: North Chicago, Illinois, United States; onsite

Salary: USD 65,500–125,500 annually

Company

hirify.global discovers and delivers medicines and healthcare solutions across areas including immunology, oncology, neuroscience, and aesthetics.

What you will do

• Assess reported clinical trial data and support safety surveillance for assigned studies.
• Review safety data for content, quality, study-level trends, and adherence to protocols and regulatory guidance.
• Plan and execute study safety reviews in collaboration with the medical monitor.
• Monitor safety-related investigator queries and provide safety overviews to clinical teams, CROs, investigators, and sites.
• Review safety sections of protocols, clinical study reports, and ad-hoc safety reports.
• Prepare narratives for serious adverse events and other events of interest while maintaining audit readiness.

Requirements

• Bachelor's degree in a related health science field.
• At least 2 years of clinical practice experience; 1 year of drug safety experience is preferred.
• Experience with clinical trial lifecycle management from preclinical and Phase III stages through launch to market.
• Proficiency with Windows, Word, Excel, and relevant clinical and laboratory databases.
• Ability to critically evaluate medical data, understand clinical courses and treatment modalities, and communicate study-related information effectively.
• Knowledge of ICH, FDA, and EMA regulatory guidance affecting safety surveillance.

Nice to have

• RN or clinical pharmacy experience.
• Drug safety experience in clinical trials.

Culture & Benefits

• Paid vacation, holidays, and sick leave.
• Medical, dental, and vision insurance for eligible employees.
• 401(k) benefits for eligible employees.
• Eligibility to participate in short-term incentive programs.
• Opportunity to contribute to departmental process improvement projects.