Pharmacovigilance Operations Manager

United States·Bothellmid

OperationsOperations Manager

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Quick Summary

Overview

Company Overview Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies.

Key Responsibilities

Safety Case Management Oversight Oversee safety case processing activities performed by Immunome’s PV vendors, including AE/SAE intake, assessment, follow up , MedDRA coding, and regulatory submissions.

Requirements Summary

Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Nursing, or related scientific field. Advanced scientific or clinical degree preferred .

Technical Tools

OperationsOperations Manager

Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. We are advancing an innovative portfolio of therapeutics, supported by a leadership team with deep experience in the design, development, and commercialization of cutting-edge therapies, including antibody-drug conjugates. Our pipeline includes varegacestat, an investigational gamma secretase inhibitor for which an NDA has been submitted to the U.S. FDA; IM-1021, a clinical-stage ROR1 ADC; IM-3050, an IND-cleared FAP-targeted radiotherapy; and IM-1617, an IND-cleared solid tumor ADC. We are also advancing a broad portfolio of early-stage ADCs pursuing undisclosed solid tumor targets.

Position Overview

The Pharmacovigilance (PV) Operations Manager at Immunome is responsible for managing day-to-day global safety operations across Immunome’s clinical stage oncology programs as well as commercial product(s). This role oversees case management activities conducted by external safety vendors, supports clinical study teams on safety matters, and ensures timely and compliant safety reporting in alignment with global regulatory requirements and Immunome’s internal standards. 

As a growing biotechnology organization, Immunome requires an adaptable and highly organized PV Operations Manager who can support cross functional communication, maintain inspection ready safety systems, and drive operational excellence across all PV workflows. 

Responsibilities