Manager, Global ICSR Management

📋 Description

• Oversee ICSR triage, case processing, and inline quality control to meet timelines.
• Monitor workflows, prioritize activities, and resolve issues to hit KPIs.
• Lead SAE reconciliation between safety and clinical databases; track progress.
• Define and analyze metrics; drive corrective actions with Process Excellence.
• Lead continuous improvement across ICSR management and workflows.
• Escalate policy and governance questions; contribute to documentation.

🎯 Requirements

• Bachelor's degree in life sciences or healthcare; advanced degree preferred.
• 5+ years in pharmacovigilance, drug safety, or clinical environments with training/oversight
• Strong knowledge of global PV/regulatory requirements (ICH, GVP, FDA, GCP).
• Hands-on ICSR processing knowledge: data intake, triage, coding, narratives, due diligence, quality
• Experience with safety databases (ideally Argus Safety) and MS Office (Excel, PowerPoint, Visio).
• Ability to analyze metrics and translate data into improvements.

🎁 Benefits

• Fully remote opportunity based in Brazil.
• Global pharmacovigilance environment and exposure to international regulatory requirements.
• Opportunities for process excellence and tech-driven efficiencies.
• Professional development through mentoring and cross-functional collaboration.
• Leadership opportunities and team development.
• Inclusive, multicultural environment with patient safety focus.