Director – Safety Scientist

🕒 July 28

🇺🇸 United States – Remote

💵 $185.1k - $245.1k / year

⏰ Full Time

🔴 Lead

👔 Director

👻 Ghost score 12%

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Logo of BeOne Medicines

BeOne Medicines

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

• 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

🎯 Requirements

• 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

🏖️ Benefits

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

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