Senior Specialist, 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

• Independently triage individual case safety reports (ICSRs) • Process and perform quality control of ICSRs from clinical trials, post-market spontaneous and solicited sources, literature, and other sources • Ensure completeness, accuracy, quality, compliance, and regulatory submission timelines • Perform SAE reconciliation between safety and clinical databases • Track reconciliation, resolve or escalate issues, and meet internal and external timelines • Meet quality, compliance, productivity, and volume KPIs • Identify and execute continuous improvement opportunities within ICSR management • Make process decisions consistent with operational policies, SOPs, and work instructions • Execute ICSR activities under PV agreements and contracts with vendors/CROs • Deliver training to new team members and develop or update training materials • Provide onboarding feedback and support issue resolution or escalation to the line manager

🎯 Requirements

• Fluent English required • Minimum bachelor’s degree in life sciences, clinical medicine, nursing, pharmacy, another healthcare profession, or equivalent combination of relevant education or professional experience • Minimum 2 years’ experience in drug safety/pharmacovigilance or relevant clinical experience, including training • Understanding of global regulatory requirements, including ICH, GVP, FDA 21 CFR 312.32 and 314.80, GCP, NMPA requirements, and other global regulations • Understanding of pharmacovigilance ICSR capture and submissions to FDA, CDE/NMPA, EMA, MHRA, and other regulatory authorities • Understanding of databases and case processing activities, including data acquisition/intake, triage, coding, narrative construction, and due diligence • Excellent verbal and written communication skills • Strong problem-solving skills • Effective time management skills • Results orientation and strong attention to detail • Argus Safety database required • MS Office suite, Excel, PowerPoint, and Visio knowledge • Digital skills preferred

🏖️ Benefits

• Equal opportunity employer and nondiscrimination protections • Training and onboarding support • Continuous learning opportunities • Global team collaboration