Executive Director – Safety Operations

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BeOne Medicines

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 2010

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 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

• Ensure end-to-end execution, quality and continuous improvement of global safety operations activities • Oversee effective collection, processing, assessment and reporting of ICSRs against global standards • Oversee safety operations activities in clinical trials, as well as China PV activities • Oversee safety systems and reporting activities • Actively influence GPS’ operational technology strategy • Provide broad and deep technical knowledge • Support and contribute to internal GPS department development • Liaise cross-functionally to execute on PV responsibilities • Create resource requirement projections for safety operations • Recruit, retain, develop, and mentor safety operations staff • Contribute to audits and inspections • Monitor drug safety information communication and ensure timely communication

🎯 Requirements

• MD, PharmD, RN plus higher degree or international equivalent, or equivalent combination of relevant education or professional experience • Mastery of global safety regulatory requirements • Fifteen (15) years relevant experience, including training • Ten (10) years drug safety experience • Proficiency in safety report processing & operational systems • Proficiency of signal recognition, statistical techniques & trials methods & outputs • Previous management experience • Process and systems management experience preferred • Clinical experience preferred

🏖️ Benefits

• Medical • Dental • Vision • 401(k) • FSA/HSA • Life Insurance • Paid Time Off • Wellness