Senior Specialist, Global ICSR Management

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Specialist, Global ICSR Management based in Brazil.

This role is an opportunity to contribute to global pharmacovigilance operations in a fast-growing, internationally focused environment. You will independently manage individual case safety reports (ICSRs), from triage and processing through quality control. The position plays a critical role in ensuring accurate, complete, and compliant safety information reaches regulatory authorities and stakeholders. You will work across cases from clinical trials, post-market sources, literature, and other reporting channels. The role also includes SAE reconciliation, compliance monitoring, process improvement, and collaboration with vendors and CROs. As a senior specialist, you will support team development through training, onboarding, knowledge sharing, and problem solving. This is a fully remote opportunity for a detail-oriented professional who wants meaningful impact in global drug safety.

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.

How Jobgether works: We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team. We appreciate your interest and wish you the best!  Why Apply Through Jobgether?    Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.     #LI-CL1