Alumis · 8 hours ago
Senior Manager, Pharmacovigilance Safety Operations
South San Francisco, CA
Full-time
Hybrid
Senior Level
7+ years expAlumis Inc. is a precision medicines company focused on transforming the lives of patients with autoimmune diseases. The Senior Manager, Pharmacovigilance Safety Operations will oversee ICSR processing and ensure compliance with regulatory requirements while collaborating with cross-functional teams to support clinical trials and safety operations.
BiotechnologyHealth CareLife ScienceMedicalPrecision Medicine
Responsibilities
Provide end-to-end operational oversight of ICSR intake, processing, follow-up, quality control, and submissions performed by our outsourced PV vendors
Ensure accurate and timely processing of ICSR to ensure accuracy and consistency, and compliance with Alumis standard operating procedures (SOP) and PV system expectations
Lead the development and maintenance of safety management plans and submission tracking systems
Support the development and maintenance of SOPs
Coordinate internal medical review activities in collaboration with medical case reviewers
Monitor case flow to ensure timely exchange for submissions
Review operational trends and quality indicators to proactively identify risks and drive corrective actions
Collaborate with clinical operations, data management, and PV teams to perform database reconciliation for clinical trials
Track the submission of safety reports to regulatory authorities and ensure compliance with country or regional submission deadlines
Ensure all safety operations are conducted in compliance with FDA, ICH, and other relevant regulatory guidelines
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 new clinical trials study start up activities such as review Safety sections of clinical trial protocols, Informed Consent Forms, clinical database configurations, including User Acceptance Testing and Safety Case Report Forms
Collaborate with Safety Surveillance and assist in the preparation of surveillance meeting materials from safety operation perspective and assist with the development of aggregate reports, such as Development Safety Update Report (DSUR), Periodic Adverse Drug Experience Report (PADER), Periodic Benefit-Risk Evaluation Report (PBRER) by performing various activities such as quality control
Contribute to PV system audit-readiness and support inspections activities
Qualification
Required
Bachelor's degree in life sciences, pharmacy, or a related field
Minimum of 7+ years of experience in safety operations in the biopharmaceutical industry
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 and manage multiple projects simultaneously
Leads self by managing and executing own work to deliver results that contribute to accomplishing common department goals
Proficiency in safety databases and software tools (e.g., Oracle Argus, ARISg, MedDRA)
Preferred
Experience with early and late-stage clinical trials (Phase 3) and post-marketing are highly desirable
Experience with device safety reporting and regulatory inspections is a plus
Company
Alumis
Alumis is a precision medicine company focused on the discovery, development and treatment of autoimmune disorders.
51-200 employees
Funding
Current Stage
Public CompanyTotal Funding
$917.19MKey Investors
Foresite CapitalMatrix Capital Management
2026-01-07Post Ipo Equity· $345.1M
2025-11-19Post Ipo Secondary· $3.09M
2024-07-23Post Ipo Equity· $40M
Leadership Team
Martin Babler
Chairman, President and CEO
K
Ken A Brameld
Fellow, Head of Discovery
Recent News
thefly.com
2026-01-16
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