Senior Specialist, Global ICSR Management

📋 Description

• Independently manage ICSR triage, case processing, and quality control after training and quality
• Manage safety cases from multiple sources: clinical trials, post-market reports, literature; ensure
• Perform SAE reconciliation between safety and clinical databases; track items, resolve
• Meet KPIs for quality, compliance, productivity, and reporting timelines.
• Apply operating policies, SOPs, and work instructions in case-processing decisions.
• Support ICSR-related activities with vendors and CROs per pharmacovigilance agreements.

🎯 Requirements

• Bachelor’s in life sciences or healthcare; advanced degree in global patient safety preferred.
• At least 2 years in drug safety/pharmacovigilance or relevant clinical activities.
• Working knowledge of global pharmacovigilance/regulatory requirements (ICH, GVP, FDA, GCP
• Understanding of ICSR case-processing (data intake, triage, coding, narrative development, due
• Experience with pharmacovigilance databases; Argus Safety preferred/required.
• Fluent English; strong written/verbal communication; detail-oriented with analytical skills.

🎁 Benefits

• Fully remote position based in Brazil.
• Full-time role in a global pharmacovigilance/patient-safety environment.
• Opportunity to work on international ICSR activities across multiple regulatory markets.
• Exposure to clinical-trial and post-market safety data from diverse sources.
• Professional development through training, onboarding, and knowledge sharing.