Manager, Global ICSR Management

Job description

Accountabilities: Oversee ICSR triage, case processing, in-line quality control, workflow management, and timely completion of safety activities in accordance with internal and external requirements. Lead and monitor SAE reconciliation between safety and clinical databases, ensuring completion, identifying discrepancies, and resolving or escalating issues. Establish, monitor, and analyze quality, compliance, productivity, and volume KPIs, partnering with process excellence teams to identify root causes and implement corrective actions. Drive continuous improvement initiatives across ICSR management, including process optimization, productivity enhancements, automation, and technology efficiency initiatives. Review workflow and case prioritization, balance team workloads, and ensure operational targets and regulatory timelines are consistently achieved. Make decisions on escalated operational issues and contribute to the development and improvement of policies, SOPs, work instructions, and procedural documentation. Support audit and inspection readiness and serve as a subject matter expert during audits and regulatory inspections. Communicate pharmacovigilance agreement and contract information to relevant teams and contribute to vendor and CRO-related activities. Lead or participate in cross-functional projects and represent ICSR Management expertise across broader organizational initiatives. Deliver training and onboarding support for new team members, maintain training materials, monitor onboarding progress, and provide feedback to leadership. Execute safety database study configuration testing when required and support initiatives designed to strengthen operational quality and compliance. Mentor team members, support their professional development, contribute to recruitment activities, and take on team leadership responsibilities across global sites as needed. 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 drug safety, pharmacovigilance, or relevant clinical operations, including experience providing or supporting training. Strong knowledge of global pharmacovigilance and regulatory requirements, including ICH, GVP, FDA requirements, GCP, NMPA/CDE requirements, and regulations applicable to individual and aggregate safety reporting. Experience supporting pharmacovigilance reporting requirements involving regulatory authorities such as FDA, EMA, MHRA, CDE/NMPA, and other national competent authorities. Hands-on understanding of ICSR case processing activities, including data intake, triage, coding, narrative development, follow-up, due diligence, and database management. Experience working with Argus Safety or comparable safety databases, along with strong proficiency in Microsoft Office tools such as Excel, PowerPoint, and related digital platforms. Strong understanding of clinical concepts, therapeutic-area patient populations, and relevant drug classes. Demonstrated ability to manage projects, prioritize competing demands, and consistently deliver accurate, high-quality work within strict timelines. Experience overseeing team deliverables and representing functional responsibilities during audits, inspections, and compliance activities. Excellent written and verbal English communication skills; fluent English is required, and all application materials should be submitted in English. Strong analytical, problem-solving, organizational, and decision-making skills, with exceptional attention to detail. Ability to work effectively across cultures and time zones within a global organization. A collaborative, inclusive, results-oriented mindset, combined with initiative, adaptability, continuous learning, and a strong sense of ownership. Willingness to travel approximately 5% of the time. Benefits Remote work opportunity based in Brazil. Full-time position within a global, fast-growing pharmaceutical and biotechnology environment. Opportunities to work on high-impact pharmacovigilance activities supporting patient safety. Professional development and continuous learning opportunities. Exposure to global regulatory requirements, cross-functional projects, audits, inspections, and process excellence initiatives. Opportunities to mentor colleagues and contribute to team development and leadership initiatives. Collaborative, multicultural work environment with colleagues across multiple regions. Opportunity to influence operational processes, quality standards, productivity, and technology-enabled improvements. Employee-focused culture emphasizing teamwork, excellence, innovation, inclusion, and continuous improvement. Compensation and additional benefits are subject to the partner company's applicable employment terms and local policies. 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 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 an opportunity to lead critical global pharmacovigilance operations within a fast-growing, international environment focused on improving patient safety.You will oversee individual case safety report (ICSR) triage, processing, quality control, workflow, and compliance activities.The role combines operational leadership with data-driven process improvement, helping ensure high-quality and timely safety reporting worldwide.You will work across global regulatory frameworks and collaborate with clinical, safety, quality, and cross-functional teams.As a subject matter expert, you will contribute to audits, inspections, process initiatives, training, and technology-driven efficiencies.The position offers meaningful ownership, exposure to global stakeholders, and opportunities to influence how pharmacovigilance operations evolve.This is a remote role in Brazil, requiring strong English communication and a proactive, collaborative approach.