Senior Manager, Pharmacovigilance Safety Operations

Alumis•South San Francisco, CA

4h•Hybrid

About The Position

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 Senior Manager, Pharmacovigilance (PV) Safety Operations will report to the Director, PV Safety Operations. This role will play a critical role in ensuring timely reporting, processing, and submission of ICSRs from ongoing clinical trials and post-marketing trials. This role involves overseeing case processing vendors, managing ICSR process, collaborating with cross-functional teams study execution teams, assisting with inspection readiness activities, all while compliance with regulatory requirements.

Requirements

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).

Nice To Haves

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.

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.