Manager, 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 Manager, Global ICSR Management based in Brazil.

This is a senior pharmacovigilance role responsible for overseeing global Individual Case Safety Report (ICSR) management, with a strong focus on quality, compliance, and operational efficiency. You will monitor triage, case processing, quality control, workflow, and safety reconciliation activities across a global environment. The role combines operational oversight with process improvement, data-driven performance management, and regulatory compliance. You will act as a subject matter expert on ICSR processes and contribute to audits, inspections, cross-functional initiatives, and technology improvements. Working with teams across multiple locations, you will help resolve complex issues, strengthen processes, and maintain high standards for patient safety. This opportunity is well suited to an experienced pharmacovigilance professional who is analytical, collaborative, and comfortable making decisions in a regulated environment. The role is remote in Brazil, with limited travel of approximately 5%.

Accountabilities:: Oversee ICSR triage, case processing, and in-line quality control activities, ensuring cases are completed accurately and within internal and external timelines.

Monitor workflows, prioritize case activities, balance workloads, and resolve or escalate processing issues to ensure operational targets and KPIs are consistently achieved.

Lead and oversee SAE reconciliation activities between safety and clinical databases, tracking progress, reviewing reconciliation plans, and resolving or escalating discrepancies.

Define, monitor, and analyze quality, compliance, productivity, and volume metrics, partnering with Process Excellence teams to identify trends, conduct root-cause analysis, and implement corrective actions.

Drive continuous improvement initiatives across ICSR Management, including process optimization, productivity enhancements, technology efficiencies, and workflow improvements.

Make decisions on escalated operational issues involving policies, SOPs, work instructions, and governance requirements, while contributing to the development and revision of procedural documentation.

Represent the pharmacovigilance function as a subject matter expert in audits, inspections, readiness activities, and cross-functional projects.

Support vendor and CRO activities by communicating relevant pharmacovigilance agreement and contract information and ensuring operational alignment.

Lead or participate in cross-functional projects and critical process initiatives, providing ICSR expertise to stakeholders across the organization.

Deliver onboarding and training for new team members, maintain training materials, monitor onboarding progress, and provide coaching and feedback.

Support study configuration testing within safety databases when required.

Mentor team members, contribute to recruitment and development activities, and take team-lead responsibilities across global sites as business needs require.

Requirements:

Bachelor's degree in life sciences, clinical medicine, nursing, pharmacy, another healthcare discipline, or an equivalent combination of education and relevant professional experience; an advanced degree is preferred.

At least 5 years of experience in pharmacovigilance, drug safety, or relevant clinical environments, including experience with training and operational oversight.

Strong understanding of global pharmacovigilance and regulatory requirements, including ICH, GVP, FDA regulations, GCP, and requirements applicable to major global regulatory authorities.

Hands-on knowledge of ICSR case processing activities, including data intake and acquisition, triage, medical coding, narrative development, due diligence, and case quality management.

Experience working with safety databases, ideally including Argus Safety, as well as strong proficiency with Microsoft Office tools such as Excel, PowerPoint, and Visio.

Demonstrated ability to establish and analyze operational, quality, compliance, productivity, and volume metrics and translate data into actionable improvements.

Experience supporting audits and inspections and confidently representing functional responsibilities and processes as a subject matter expert.

Strong project and time management skills, with the ability to deliver high-quality work within strict regulatory and operational timelines.

Excellent written and verbal English communication skills, with the ability to collaborate effectively across global and multicultural teams.

Strong analytical, problem-solving, decision-making, and organizational skills, combined with exceptional attention to detail.

A collaborative, inclusive, results-oriented mindset with the initiative and adaptability to work effectively in a changing global environment.

Experience mentoring or supervising team members and coordinating deliverables across multiple locations is advantageous.

Willingness to travel approximately 5% as required.

Benefits:

Fully remote opportunity based in Brazil.

Opportunity to work in a global pharmacovigilance and drug safety environment.

Exposure to complex international regulatory requirements and cross-functional initiatives.

Opportunities to contribute to process excellence, continuous improvement, and technology-driven efficiencies.

Professional development through mentoring, training, and collaboration with global teams.

Opportunity to take on leadership responsibilities and support team development.

Inclusive, collaborative, and multicultural working environment.

Meaningful opportunity to contribute to processes that support patient safety and the responsible use of medicines.

Approximately 5% travel, offering opportunities for global collaboration while maintaining a remote working model.

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