Senior PV Operations Specialist

Job Description

Job Description

The role supports the Senior Director of Pharmacovigilance (PV) Operations in managing Systimmune’s PV function, with full accountability for end-to-end case processing (including submissions), ability to work in the safety database, and CAPA coordination. It ensures data integrity, system performance, and compliance with global regulations and internal SOP.

The role will be involved in working cross-functionally with internal departments / key stakeholders and external partners on pharmacovigilance-related matters.

This is not a remote role and requires in-office presence at least three days per week.

Key Responsibilities

• 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, work instructions, and applicable regulations (e.g., FDA, EMA, ICH).
• Support continuous improvement initiatives within PV operations.
• Facilitate the generations of listings for the periodic safety reports (e.g., DSUR, PSUR).
• Work with the QA department to maintain a state of high PV inspection readiness across all regions / countries.
• Support the performance of root cause analysis of deviations relevant to PV systems.
• Prepare responses to audit findings that concern the PV department.
• Manage reconciliation activities with other departments within the company and vendors.

Qualifications

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