Manager, Global ICSR Management

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BeOne Medicines

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 2010

🧬 Biotechnology

🏥 Healthcare

💊 Pharmaceuticals

Biotechnology • Healthcare • Pharmaceuticals

BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting the development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. With a growing global team of more than 11,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them.

📋 Description

• Oversee triage, case processing, and in-line quality control for individual case safety reports. • Monitor, define, and set efficiency, quality, compliance, productivity, and volume metrics. • Analyze and resolve issues, including root cause analysis, late case investigations, and corrective actions. • Oversee and improve SAE reconciliation between safety and clinical databases. • Review workflow and prioritize case processing to meet internal and external timelines. • Balance team workload and ensure target KPIs are met. • Make process decisions on escalated operational policy, SOP, and work-instruction issues. • Drive changes to processes and procedures and assist with creating procedural documents. • Support audits and inspections as a subject matter expert and execute readiness activities. • Manage vendor/PV agreement information and support CRO-related activities. • Lead or participate in cross-functional ICSR projects and process excellence initiatives. • Deliver training, develop training materials, and support new team member onboarding. • Execute study configuration testing in the safety database as needed. • Mentor team members, provide development opportunities, and contribute to staff recruitment.

🎯 Requirements

• Fluent English is required. • Minimum bachelor’s degree in life sciences, clinical medicine, nursing, pharmacy, another healthcare profession, or equivalent relevant education/professional experience. • Minimum 5 years’ experience in drug safety/pharmacovigilance or relevant clinical experience, including training. • Strong understanding of global regulatory requirements, including ICH, GVP, FDA 21 CFR 312.32 and 314.80, GCP, NMPA requirements, and PAL of PRC. • Knowledge of pharmacovigilance individual case safety report and aggregate safety report submissions to FDA, CDE/NMPA, EMA, MHRA, and other global regulatory authorities. • Proficiency in safety databases and case processing, including data acquisition/intake, triage, coding, narrative construction, and due diligence. • Clinical knowledge of therapeutic-area patient populations and drug classes. • Experience with project and time management strategies. • Ability to oversee team deliverables and represent functional responsibilities in audits and inspections. • Excellent verbal and written communication skills. • Strong problem-solving skills, results orientation, and attention to detail. • Global culture awareness. • Argus Safety database and other platforms required. • Microsoft Office suite, Excel, PowerPoint, and Visio knowledge. • Ability to travel approximately 5%. • Advanced degree preferred.

🏖️ Benefits

• Equal opportunity employment • Travel: 5% • Global team environment • Opportunities for growth and development • Training and onboarding support