Associate Director, Safety Scientist

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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

• Focus on early development (phase I) and late-stage (phase II–III) safety science activities • Conduct safety assessment and safety risk management activities based on ICH standards • Provide safety expertise for assigned developmental and/or marketed products with Product Safety Physician Leads and Safety Physicians • Represent the GPS department internally and externally at a global level • Lead signal evaluation and safety monitoring activities • Contribute to pharmacovigilance, benefit/risk, and regulatory activities and interactions • Identify, analyze, and evaluate safety signals from internal and external data sources • Lead data acquisition strategies and safety data analyses; author safety assessment reports • Collaborate with PSLs, scientists, pharmacoepidemiologists, and cross-functional personnel on aggregate safety analysis • Prepare and present safety data for Safety Management Team, Company Safety Committee, SMC, DMC, and DSMB meetings • Develop, update, and review safety communication documents and labeling materials • Review safety data and monitor patient safety in allocated clinical trials • Write and review safety sections for protocols, IBs, ICFs, SAPs/TFLs, Medical Monitoring Plans, CSRs, and other study documents • Author and review safety sections of regulatory submissions and regulatory inquiry responses • Author storyboards and briefing books for health-authority interactions • Maintain Safety Management Plans and lead Safety Science-specific investigator training • Analyze safety data and author safety sections of periodic reports, including DSURs and PADERs • Perform other departmental tasks assigned by the manager

🎯 Requirements

• PharmD or PhD in a medical field or biological science and 4+ years of experience in pharmacovigilance in an analytical role, OR RN with 8+ years in pharmacovigilance in an analytical role, OR MD (or internationally recognized equivalent) plus accredited residency or comparable post-medical-school clinical training • At least 4 years of clinical experience with patients in a relevant therapeutic-area specialty • Significant knowledge of general medicine • 2+ years of pharmaceutical/biotechnology industry experience in Safety Science, Clinical Development, or Clinical Research is preferred • US-trained physicians must have achieved board eligibility or certification • Physicians trained outside the US who are not US board eligible or certified may be hired directly for employment in the US at the discretion of the Chief Safety Officer or appropriate delegate • Intermediate knowledge of working with a safety database for retrieval of safety information • Advanced knowledge of MedDRA • Advanced application capability with Excel, PowerPoint, and Word • Familiarity with data mining and exploratory analysis tools such as Spotfire • Ability to travel less than 10%

🏖️ Benefits

• Full-time employment • Remote work • Less than 10% travel • Equal opportunity employment