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Regulatory Compliance Specialist
2 months ago
Overview
Alumis Inc. is a precision medicines company dedicated to transforming the lives of patients with autoimmune diseases. Our mission is to fundamentally change the outcomes for these patients.
Job Summary
The Safety Operations 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
- Reporting and Submission
- 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.
- Safety Management
- 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.
- Vendor Management
- Manage and monitor safety vendor performance and perform quality control through regular review of KPIs and adherence to service level agreements.
- Regulatory Compliance
- 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.
- Documentation
- Assist in the preparation of safety sections for clinical study protocols, ICF, and other documentation.
- Quality Assurance
- 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.
Company Culture
- 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.
