Senior PV Case Manager - GxP Compliance & Inspections

CSL; King (AR); On-site; USD 120,000 - 170,000; Full time

Job summary

CSL Behring is seeking a Case Management subject matter expert to lead global pharmacovigilance activities within cross-functional teams for assigned clinical trials. You will ensure compliance with GxP and international regulations, manage safety reporting plans, and oversee vendor performance in PV operations.

Responsibilities include coordinating ICSR reporting, CAPA/SOP development, regulatory inspections preparation, and training external vendors to uphold high safety data standards across

Qualifications

• Pharmacovigilance experience in a multinational pharmaceutical environment (7+ years).
• Strong knowledge of local and international PV regulations and GxP.
• Experience with regulatory inspections and audits.
• Experience handling large datasets and complex data management.

Responsibilities

• Acts as Case Management SMEx in cross-functional teams for trials.
• Manages case management activities to ensure compliance with GxP regulations and company policies.
• Delivers Safety Reporting Plans and monitors PV KPIs/KQIs across activities.
• Supports PV inspections and audits as required.
• Maintains clinical trial case management documents per regulations and internal standards.
• Oversees vendors to ensure GSPV standards in handling SAE/AESI/pregnancy cases and expedited reporting.
• Primary contact for external vendors for GSPV PV Operations queries.
• Provides study-specific training to external vendors and PV team members.
• Develops and oversees pharmacovigilance procedures to ensure timely processing and analysis of safety data.
• Ensures correct coding of all event and drug terms; maintains consistency in case evaluations.
• Leads ICSR reporting compliance analyses and CAPAs from vendors.
• Collaborates internally and with external partners to meet regulatory reporting requirements.
• Oversees preparation of SUSARs for submission to regulators and may lead cross-functional projects to improve inspection readiness.

Skills

Pharmacovigilance

GxP regulations

Regulatory inspections

Data analysis

CAPA & SOPs

Software applications

Education

Bachelor's in Life Sciences

Master's/PhD preferred

Tools

Regulatory software

Job description

CSL Behring is seeking a Case Management subject matter expert to lead global pharmacovigilance activities within cross-functional teams for assigned clinical trials. You will ensure compliance with GxP and international regulations, manage safety reporting plans, and oversee vendor performance in PV operations.

Responsibilities include coordinating ICSR reporting, CAPA/SOP development, regulatory inspections preparation, and training external vendors to uphold high safety data standards across