Senior PV Operations Specialist
SystimmuneNew Jersey, United States
Posted October 2, 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
This Senior PV Operations Specialist role supports the Senior Director of Pharmacovigilance (PV) Operations by managing PV function, ensuring data integrity, CAPA coordination, and compliance with regulations. It involves cross-functional collaboration and continuous improvement in an in-office setting (minimum three days/week).
Requirements
- 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 and work instructions.
