Senior Specialist, Global ICSR Management

📋 Description

• Perform ICSR triage, case processing, and quality control across sources.
• Ensure reports meet completeness, accuracy, and regulatory submission requirements.
• Conduct SAE reconciliation between safety and clinical databases.
• Identify, investigate, and resolve discrepancies in SAE reconciliation and case management.
• Meet KPIs for quality, compliance, and productivity in case processing.
• Apply SOPs and WIs in decision making.

🎯 Requirements

• Bachelor’s in life sciences or related field; healthcare experience preferred.
• Advanced training in global patient safety or pharmacovigilance preferred.
• At least 2 years in drug safety or pharmacovigilance.
• Strong knowledge of ICH, GVP, FDA regs, GCP, EMA, MHRA, NMPA/CDE.
• Practical ICSR case management knowledge; data intake, triage, coding, narratives, quality control.
• Experience with Argus Safety or similar safety databases.

🎁 Benefits

• Fully remote work arrangement based in Brazil.
• Full-time employment opportunity.
• Global pharmacovigilance and patient-safety exposure.
• Work with international regulatory requirements and ICSR workflows.
• Opportunities for professional development and process improvement.
• Collaborative international environment with focus on safety and innovation.