Manager/Senior Manager, PV Operation
SystimmuneNew Jersey, United States
Posted August 14, 2025
Full Time
About the Company
Systimmune Inc., founded in 2014 in Redmond, WA, is a bio-pharmaceutical company specializing in the development of novel bi-specific and tri-specific antibodies, as well as antibody-drug conjugates (ADCs) for cancer treatment. The company focuses on systematically intervening in the solid tumor micro-environment to either directly attack tumors or activate the immune system. Led by experienced immuno-oncology scientists, Systimmune leverages advanced technology platforms to create world-class antibody-based drug therapies.
Job Description
The Manager/Senior Manager of PV Operation will be responsible for the pharmacovigilance function, ensuring compliance with SOPs and regulations. This role involves vendor management, quality system oversight, safety data exchange, and CAPA management. The position requires cross-functional collaboration and working with both internal and external stakeholders.
Requirements
- Coordinate daily management and execution of drug safety and pharmacovigilance operations.
- Work with regulatory compliance, PV agreements, and internal SOPs.
- Represent the department on clinical development teams.
- Oversee SAE (Serious Adverse Event) processing by outsourced vendors.
- Conduct performance management of PV systems and root cause analysis.
- Prepare and submit safety reports.
- Manage both quality and compliance of assignments.
