Senior Global Case Manager, (ICSR Case Processing) Title: Senior Specialist, Global ICSR Case Processing & QCDepartment: Global Patient SafetyOverview: Seeking an experienced Senior Specialist in Global ICSR Case Processing & QC to independently manage the processing and quality control of individual case safety reports (ICSRs), ensuring regulatory compliance and excellence in data accuracy, completeness, and quality.Key Responsibilities:ICSR Case Processing: Manage case processing and quality control of ICSRs from diverse sources (e.g., clinical trials, post-market, literature) to ensure timely, accurate submissions to regulatory authorities.SAE Reconciliation: Perform SAE reconciliations between safety and clinical databases, track progress, resolve issues, and escalate when necessary.Quality & Compliance: Adhere to KPI and quality metrics, ensuring productivity and process improvement within ICSR management.Decision-Making: Execute decisions in line with operational policies, SOPs, and work instructions.Vendor/CRO Coordination: Ensure ICSR activities align with PV agreements and contracts.Training & Onboarding: Develop and update training materials, onboard new team members, provide feedback, and support the onboarding process.Qualifications:Bachelor's degree in life sciences, clinical medicine, nursing, pharmacy, or equivalent experience; advanced degree preferred.Proficiency with Argus safety database and MS Office Suite.Minimum 2 years of experience in drug safety/pharmacovigilance or relevant clinical experience; preferred 5-8 years of experience.Strong understanding of global regulatory requirements (e.g., ICH, FDA, EMA, MHRA) for pharmacovigilance reporting.Excellent communication, problem-solving, time management, and attention to detail.Global cultural awareness and collaborative mindset.#J-18808-Ljbffr