Senior Manager, Pharmacovigilance Safety Operations

Role Summary

The Senior Manager, Pharmacovigilance (PV) Safety Operations will report to the Director, PV Safety Operations. This role ensures timely reporting, processing, and submission of ICSRs from ongoing clinical trials and post-marketing trials. It oversees case processing vendors, manages the ICSR process, and collaborates with cross-functional teams to support inspection readiness and regulatory compliance. Location: South San Francisco, CA; onsite Tue–Thu; remote applicants in the Pacific Time Zone may be considered; travel to HQ approximately monthly as needed.

Responsibilities

• Provide end-to-end operational oversight of ICSR intake, processing, follow-up, quality control, and submissions performed by outsourced PV vendors.
• Ensure accurate and timely processing of ICSRs in alignment with Alumis SOPs 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.

Qualifications

• Bachelor’s degree in life sciences, pharmacy, or a related field.
• Minimum of 7+ years of experience in safety operations in the biopharmaceutical industry.
• 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.
• 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.
• Leads self by managing and executing own work to deliver results that contribute to accomplishing common department goals.

Skills

• Excellent organizational, analytical, and communication skills.
• Proficiency in safety databases and software tools (e.g., Oracle Argus, ARISg, MedDRA).