PV Operations Specialist

The PV Operations Specialist role supports the Senior Director of Pharmacovigilance (PV) Operations and is responsible for end-to-end safety case processing, regulatory submissions, and CAPA coordination. The role ensures data integrity and compliance with global PV regulations and SOPs, requires collaboration with internal stakeholders and external vendors, and is an on-site position with a minimum in-office presence of three days per week. Responsibilities include intake, triage, data entry, and quality review of ICSRs; timely regulatory submissions; accuracy of safety data in PV databases; cross-functional audits and CAPA implementation; adherence to SOPs and regulatory requirements (FDA, EMA, ICH); supporting periodic safety reports (DSUR, PSUR); working with QA to maintain inspection readiness; root cause analysis of PV deviations; and preparing responses to audit findings. Compensation includes a base salary in the 85k-115k range and a comprehensive benefits package; SystImmune is an Equal Opportunity Employer.