Manager, Safety Scientist

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $127.8k - $167.8k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

👔 Manager

👻 Ghost score 1%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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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

• Support assigned compounds in conjunction with Product Safety Leads to conduct signal detection, safety data evaluation, safety risk assessment, regulatory inquiry responses, and periodic reporting • Identify, analyze, and evaluate safety data from applicable sources • Perform signal detection and assessment with required documentation • Support data acquisition strategies and author safety assessments • Collaborate with Safety Leads, scientists, pharmacoepidemiologists, and cross-functional personnel on safety data evaluation and aggregate analysis • Prepare and present safety data for Safety Management Team, Company Safety Committee, Safety Monitoring Committee, Data Monitoring Committee, and DSMB meetings • Lead and facilitate safety team meetings and communicate relevant safety information to stakeholders • Develop, update, and review safety communication documents • Review safety data and monitor patient safety in allocated clinical trials • Write and review safety sections of protocols, IBs, ICFs, SAPs, TFLs, Medical Monitoring Plans, CSRs, and other study documents • Contribute to aggregate reports including PBRERs, DSURs, and PADERs • Author and review safety sections of regulatory submissions • Author Storyboards and Briefing Books for health-authority interactions • Support investigator training and Safety Management Plan reviews • Analyze safety data and author safety sections of regulatory inquiries and periodic reports • Respond to safety questions from health authorities and IRBs/ECs • Assist with integrated benefit/risk assessments • Perform other departmental tasks assigned by the manager

🎯 Requirements

• PharmD, RN or PhD/MS in a medical field or biological science • 2+ years as a Safety (Pharmacovigilance) Scientist • Pharmaceutical product development experience • Experience with global regulatory requirements for pharmacovigilance • Knowledge working with a safety database such as Argus for retrieval of safety information • Intermediate knowledge of MedDRA and signal management systems • Advanced application capability with Excel, PowerPoint, Word, and an electronic document management system such as Veeva • Familiarity with data mining and analysis tools such as Spotfire and Power BI • Ability to travel less than 10%

🏖️ Benefits

• Annual bonus plan eligibility for Non-Commercial roles • Discretionary equity awards • Employee Stock Purchase Plan • Medical • Dental • Vision • 401(k) • FSA/HSA • Life Insurance • Paid Time Off • Wellness