Hybrid Pharmacovigilance Operations Specialist

SystImmune, Inc.; Princeton (NJ); Hybrid; USD 85,000 - 115,000; Full time

Benefits offered by this job

100% paid medical/dental/vision

Short-term disability

Long-term disability

401(k) match

PTO 15 days

11 paid holidays

Job summary

SystImmune, Inc. is seeking a PV Operations Specialist to support the Senior Director of Pharmacovigilance. You will oversee end-to-end safety case processing, ensure data integrity in the PV database, and coordinate regulatory submissions across global markets.

The role requires 3–5+ years in pharmacovigilance, a life sciences degree, and familiarity with safety databases such as ArisG or Argus. This hybrid position offers 3 days in-office and a comprehensive benefits package.

Qualifications

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

Responsibilities

• Perform intake, triage, data entry, and quality review of cases.
• 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 (FDA, EMA, ICH).
• Support continuous improvement initiatives within PV operations.
• Facilitate generation of listings for periodic safety reports (DSUR, PSUR).
• Work with QA to maintain PV inspection readiness across regions.
• Support root cause analysis of PV-related deviations.
• Prepare responses to audit findings for PV department.
• Manage reconciliation activities with other departments and vendors.

Skills

Pharmacovigilance

Attention to detail

Independent worker

Cross-functional collaboration

Education

Bachelor’s degree in life sciences/related field

Tools

ArisG

Argus

Job description

SystImmune, Inc. is seeking a PV Operations Specialist to support the Senior Director of Pharmacovigilance. You will oversee end-to-end safety case processing, ensure data integrity in the PV database, and coordinate regulatory submissions across global markets.

The role requires 3–5+ years in pharmacovigilance, a life sciences degree, and familiarity with safety databases such as ArisG or Argus. This hybrid position offers 3 days in-office and a comprehensive benefits package.