Associate Director – Safety Scientist

🔥 18 hours ago

🇧🇷 Brazil – Remote

⏰ Full Time

🟠 Senior

👔 Director

👻 Ghost score 11%

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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 • Perform high-quality and timely scientific and operational safety analysis within a matrix team • Conduct safety assessment and safety risk management activities based on ICH standards and applicable regulations • 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, regulatory activities, and regulatory interactions • Identify, analyze, and evaluate safety signals from internal and external data sources • Propose and lead data acquisition strategies, methodologies, and approaches for safety evaluations • Author safety assessment reports and analyze safety data • Collaborate with PSLs, scientists, pharmacoepidemiologists, and cross-functional personnel • Prepare and present safety data for Safety Management Team, Company Safety Committee, SMC, DMC/DSMB, and other governance meetings • Lead safety team meetings and communicate relevant safety information to stakeholders • Develop, update, and review safety communication documents and labeling/risk-management materials • Perform signal detection and assessment with required documentation • Lead safety review and monitoring of patients on allocated clinical trials • Write and review safety sections for protocols, IBs, ICFs, SAPs/TFLs, Medical Monitoring Plans, CSRs, and other study documents • Answer ad-hoc safety queries from ethics committees • Author and review safety sections of IND/CTA, NDA/MAA, and other regulatory submissions • Author storyboards and briefing books for health-authority interactions • Write and maintain Safety Management Plans • Lead Safety Science-specific investigator training • Analyze safety data and author safety sections of regulatory inquiries and periodic reports, including DSURs and PADERs • Promote and advance the field of pharmacovigilance • Perform other tasks assigned by the manager

🎯 Requirements

• Submit all resumes/CVs in English • Fluent English is required • PharmD or PhD in a medical field or biological science and 4+ years of experience in pharmacovigilance in an analytical role • RN with 8+ years in pharmacovigilance in an analytical role • MD (or internationally recognized equivalent) plus accredited residency or comparable post-medical school clinical training relevant to the country of hiring • For the MD pathway: 4+ years of clinical experience with patients in a relevant therapeutic area specialty • For the MD pathway: significant knowledge of general medicine • For the MD pathway: 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 • 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 • Preferred experience in the pharmaceutical/biotech industry

🏖️ Benefits

• Equal opportunity employment • Travel less than 10%