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Senior Manager of Pharmacovigilance Safety Operations

Alumis Inc.South San Francisco
On-site Full-time $170K/yr - $170K/yr

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Experience Level

Senior Level Manager

Qualifications

Essential Responsibilities include:Providing comprehensive operational oversight of ICSR intake, processing, follow-up, quality control, and submissions conducted by our outsourced PV vendors. Ensuring the accurate and timely processing of ICSR to maintain compliance with Alumis standard operating procedures (SOPs) and PV system expectations. Leading the development and maintenance of safety management plans and submission tracking systems. Supporting the development and maintenance of SOPs. Coordinating internal medical review activities in conjunction with medical case reviewers. Monitoring case flow to guarantee timely exchanges for submissions. Analyzing operational trends and quality indicators to proactively identify risks and implement corrective actions. Collaborating with clinical operations, data management, and PV teams to perform database reconciliations for clinical trials. Tracking the submission of safety reports to regulatory authorities, ensuring compliance with regional submission deadlines. Conducting all safety operations in adherence to FDA, ICH, and other relevant regulatory guidelines.

About the job

Join Alumis Inc., a pioneering precision medicines company dedicated to transforming the lives of patients with autoimmune diseases. Despite substantial advancements in treatment over the past two decades, many individuals with immunologic conditions continue to face challenges. Our mission is to fundamentally improve outcomes for these patients.

The Senior Manager of Pharmacovigilance (PV) Safety Operations will report to the Director of PV Safety Operations. This pivotal position is essential for ensuring the timely reporting, processing, and submission of Individual Case Safety Reports (ICSRs) originating from ongoing clinical trials and post-marketing studies. The role encompasses oversight of case processing vendors, management of the ICSR process, collaboration with cross-functional teams during study execution, and support for inspection readiness activities, all while ensuring strict compliance with regulatory requirements.

About Alumis Inc.

Alumis Inc. is at the forefront of precision medicine, focusing on innovative treatments for patients suffering from autoimmune diseases. Our commitment to research and development drives us to create solutions that significantly enhance patient outcomes.

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