Safety Operation Specialist

Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients.

The Safety Operation Specialist will play a critical role in ensuring timely reporting, processing, and submission of ICSRs from ongoing clinical trials. This role involves overseeing case processing vendors, managing ICSR process, tracking submissions, supporting clinical teams, and ensuring quality control, all while maintaining compliance with regulatory requirements.

Key Responsibilities

• Oversee the collection, tracking, and submission of safety information from clinical trials.
• Ensure accurate and timely processing of adverse events, serious adverse events, and other events of interest.
• Support the development and maintenance of safety management plans, standard operating procedures (SOPs), and submission tracking systems.
• Collaborate with clinical operations, data management, and pharmacovigilance teams to perform database reconciliation for clinical studies.
• Manage and monitor safety vendor performance and perform quality control through regular review of KPIs and adherence to service level agreements.
• Track the submission of safety reports to regulatory authorities and ensure compliance with country or regional submission deadlines.
• Work closely with clinical development, regulatory, and quality assurance teams to align safety operations with overall study objectives and ensure regulatory compliance
• Assist in the preparation of safety sections for clinical study protocols, ICF and other documentation.
• Ensure all safety operations are conducted in compliance with FDA, ICH, and other relevant regulatory guidelines.
• Conduct regular audits of safety data and case processing activities to identify and address discrepancies or areas for improvement.
  
  
  

Qualifications

• Bachelor’s degree in life sciences, pharmacy, or a related field.
• 3+ years of experience in safety operations in the biopharmaceutical industry.
• Experience with early and late-stage clinical trials (Phase 3) is highly desirable.
• Strong knowledge of regulatory requirements (e.g., FDA, ICH guidelines) and industry standards related to drug safety and case processing.
• Demonstrated experience in vendor oversight, submission tracking, and quality control.
• Excellent organizational, analytical, and communication skills.
• Ability to work independently and collaboratively in a fast-paced environment.
• Proficiency in safety databases and software tools (e.g., Argus, MedDRA) is a plus.
  
  
  

Alumis Values

• Elevate
• Challenge
• Nurture
  
  
  

This position is located in South San Francisco, CA. At this time we are not considering remote applicants.

The salary range for this position is $120,000 USD to $140,000 USD annually. This salary range is an estimate, and the actual salary may vary based on the Company’s compensation practices.

Alumis Inc. is an equal-opportunity employer.