Manager, Global ICSR Management

• 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.