Description

SystImmune is a leading and well-funded clinical-stage biopharmaceutical company located in Redmond, WA and Princeton, NJ. It specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs). SystImmune has multiple assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside ongoing clinical trials. SystImmune has a robust preclinical pipeline of potential cancer therapeutics in the discover and IND-enabling stages, representing cutting-edge biologics development. We offer an opportunity for you to learn and grow while making significant contributions to the company's success.

The PV Operations Specialist supports the Senior Director of Pharmacovigilance (PV) Operations in the oversight and execution of Systimmune’s global pharmacovigilance function. The position carries full accountability for end-to-end safety case processing, including regulatory submissions, hands-on work within the safety database, and CAPA management and coordination.

The incumbent is responsible for ensuring data integrity, optimal system performance, and compliance with global pharmacovigilance regulations and internal SOPs. The role requires close cross-functional collaboration with internal stakeholders and effective partnership with external vendors and service providers on pharmacovigilance-related activities.

This is an on-site position, requiring in-office presence a minimum of three days per week.

Key Responsibilities

Perform intake, triage, data entry, and quality review of ICSRs.
Ensure timely regulatory submissions in accordance with global requirements.
Maintain accuracy and completeness of safety data in the PV database.
Collaborate with cross-functional teams to support audits, inspections, and CAPA implementation.
Follow SOPs, work instructions, and applicable regulations (e.g., FDA, EMA, ICH).
Support continuous improvement initiatives within PV operations.
Facilitate the generations of listings for the periodic safety reports (e.g., DSUR, PSUR).
Work with the QA department to maintain a state of high PV inspection readiness across all regions/countries.
Support the performance of root cause analysis of deviations relevant to PV systems.
Prepare responses to audit findings that concern the PV department.
Manage reconciliation activities with other departments within the company and vendors.

Qualifications

Bachelor’s degree in life sciences, pharmacy, nursing, or related field.
3-5+ years of experience in pharmacovigilance case processing preferred.
Familiarity with safety databases (e.g., ArisG, Argus) and regulatory reporting requirements.
Strong attention to detail, organizational skills, and ability to work independently.

PV Operations Specialist

Description

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