Senior Specialist, Global ICSR Management

Accountabilities:

• • Independently perform ICSR triage, case processing, and quality control after completing the required training and demonstrating baseline quality standards.
  • Manage safety cases from multiple sources, including clinical trials, post-market spontaneous and solicited reports, and literature, ensuring completeness, accuracy, and compliance.
  • Perform SAE reconciliation between safety and clinical databases, track outstanding items, resolve discrepancies, and escalate issues when necessary.
  • Meet established quality, compliance, productivity, and volume KPIs while adhering to internal and external reporting timelines.
  • Apply operational policies, standard operating procedures, and work instructions consistently when making case-processing and workflow decisions.
  • Support ICSR-related activities involving vendors and CROs in accordance with pharmacovigilance agreements and contractual requirements.
  • Identify opportunities for process improvement and contribute to continuous improvement initiatives within global ICSR management.
  • Deliver training to new team members, develop and maintain training materials, and provide feedback on onboarding progress.
  • Support issue resolution for new team members and escalate complex matters appropriately to management.
  • Maintain a high standard of documentation, accuracy, and attention to detail across all pharmacovigilance activities.

  Requirements:

  • Bachelor’s degree in life sciences, clinical medicine, nursing, pharmacy, another healthcare discipline, or equivalent relevant professional experience; an advanced degree in global patient safety is preferred.
  • At least 2 years of experience in drug safety, pharmacovigilance, or relevant clinical activities, including applicable training.
  • Working knowledge of global pharmacovigilance and regulatory requirements, including ICH, GVP, FDA requirements, GCP, NMPA/CDE requirements, and regulations applicable to safety reporting across major global markets.
  • Understanding of ICSR case-processing activities, including data intake and acquisition, triage, medical coding, narrative development, and due diligence.
  • Experience with pharmacovigilance databases, particularly Argus Safety, is preferred or required for the relevant workflows.
  • Strong verbal and written English communication skills; fluent English is required and application materials should be submitted in English.
  • Excellent analytical and problem-solving abilities, with strong attention to detail and a results-oriented mindset.
  • Strong time-management skills and the ability to consistently manage multiple priorities while meeting strict regulatory and operational deadlines.
  • Proficiency with Microsoft Office tools, including Excel and PowerPoint; familiarity with Visio and other digital platforms is a plus.
  • Experience in the pharmaceutical or biotechnology industry is preferred.
  • Demonstrated ability to collaborate effectively, communicate clearly, take initiative, adapt to change, and contribute to continuous learning and process excellence.

  Benefits:

  • Fully remote position based in Brazil.
  • Full-time opportunity within a global pharmacovigilance and patient-safety environment.
  • Opportunity to work on international ICSR activities supporting multiple regulatory markets.
  • Exposure to clinical-trial and post-market safety data across diverse reporting sources.
  • Opportunities to develop expertise in global regulatory requirements and pharmacovigilance processes.
  • Professional development through training, onboarding, process improvement, and knowledge-sharing responsibilities.
  • Opportunity to contribute to patient safety and the delivery of innovative medicines to patients worldwide.
  • Collaborative, international work environment focused on teamwork, excellence, initiative, analytical thinking, and continuous improvement.
  • No regular travel or supervisory responsibilities required for the position.