PV Operations Lead — Onsite, Drive Safety Data Excellence

SystImmune; Princeton (NJ); On-site; USD 85,000 - 115,000; Full time

Job summary

SystImmune is a leading biotech company with a global pharmacovigilance function. The PV Operations Specialist will support the Senior Director of PV Operations, handling end-to-end safety case processing, regulatory submissions, and CAPA management.

This on-site role requires three days per week in-office presence in Princeton, NJ, enabling collaboration with cross-functional teams to ensure data integrity, timely reporting, and inspection readiness across regions.

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 (ArisG, Argus) and regulatory reporting requirements

Responsibilities

• Perform intake, triage, data entry, and quality review of ICSRs.
• Ensure timely regulatory submissions and maintain PV data accuracy in the PV database.
• Collaborate with cross-functional teams to support audits, inspections, and CAPA implementation.
• Follow SOPs, work instructions, and applicable regulations (FDA, EMA, ICH).
• Support ongoing PV operations improvements and generation of listings for DSUR/PSUR.
• Assist with PV inspection readiness across regions and reconcile activities with other departments.

Skills

Pharmacovigilance

Data entry

Attention to detail

Organizational skills

Education

Bachelor’s degree in life sciences, pharmacy, nursing, or related field

Tools

ArisG

Argus

Job description

SystImmune is a leading biotech company with a global pharmacovigilance function. The PV Operations Specialist will support the Senior Director of PV Operations, handling end-to-end safety case processing, regulatory submissions, and CAPA management.

This on-site role requires three days per week in-office presence in Princeton, NJ, enabling collaboration with cross-functional teams to ensure data integrity, timely reporting, and inspection readiness across regions.