Director – Safety Scientist

🕒 Julho 28

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BeOne Medicines

SiteLinkedInTodas as Vagas

10.000+ funcionários

Fundada em 2010

🧬 Biotecnologia

🏥 Saúde

💊 Farmacêutico

Biotechnology • Healthcare • Pharmaceuticals

A BeOne Medicines é uma empresa global de oncologia, com sede na Suíça, que descobre e desenvolve tratamentos inovadores mais acessíveis e com maior disponibilidade para pacientes com câncer em todo o mundo. Com um portfólio que abrange hematologia e tumores sólidos, a BeOne está acelerando o desenvolvimento de seu diversificado pipeline de novas terapias por meio de capacidades internas e colaborações. Com uma equipe global em crescimento, formada por mais de 11.000 colaboradores presentes em seis continentes, a empresa está comprometida em melhorar radicalmente o acesso a medicamentos para muito mais pacientes que deles precisam.

Descrição

• Support assigned compounds in conjunction with Product Safety Leads (PSLs) • Lead the detection of safety signals, evaluation of safety data, and assessment of safety risks • Perform analysis of safety data and author safety assessments • Drive collaboration with PSLs and cross-functional personnel for thorough evaluation of safety data • Lead preparation and presentation of safety data at governance meetings • Communicate relevant safety information timely to stakeholders • Lead the authoring and reviewing of safety communication documents • Support the review of safety data and monitor safety of patients on allocated clinical trials • Author safety sections of regulatory submissions and manage Safety Management Plans • Lead analysis of safety data for global regulatory inquiries and periodic reports • Promote continuous improvement in organizational effectiveness and productivity

🎯 Requisitos

• PharmD, NP, RN, or PhD in a medical field or biological science • 8+ years of experience as a Safety (Pharmacovigilance) Scientist • 4+ years of clinical experience with patients in a relevant therapeutic area specialty • 6+ years of pharmaceutical/biotechnology industry experience in Safety Science, Clinical Development, or Clinical Research • Advanced knowledge working with a safety database (i.e., Argus) • Advanced knowledge of MedDRA and signal management system • Advanced application capability with Excel, PowerPoint, Word, and electronic document management system (i.e., Veeva) • Prior matrix management team experience • Prior experience with Regulatory Agency interactions

🏖️ Benefícios

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