Manager, Safety Scientist

🔥 17 hours ago

🇧🇷 Brazil – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

👔 Manager

👻 Ghost score 10%

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 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 Product Safety Leads, scientists, pharmacoepidemiologists, and cross-functional personnel on safety evaluations and aggregate analyses • Prepare and present safety data for Safety Management Team, Company Safety Committee, Safety Monitoring Committee, and Data Monitoring Committee/Data and Safety Monitoring Board meetings • Lead and facilitate safety team meetings • Communicate relevant safety information to core teams, business partners, and stakeholders • Develop, update, and review safety communication documents • Review safety data and monitor patient safety on allocated clinical trials • Write and review safety sections for protocols, investigator brochures, informed consent forms, safety analysis plans, clinical study reports, and other study documents • Contribute to and review aggregate reports including PBRERs, DSURs, and PADERs • Support safety sections of regulatory submissions and 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 additional health authority evaluation requests and safety questions from health authorities and ethics committees • Assist with integrated benefit/risk assessments • Perform other 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 • Fluent English is required • Knowledge working with a safety database (e.g., Argus) for retrieval of safety information • Intermediate knowledge of MedDRA and signal management system • Advanced application capability with Excel, PowerPoint, Word, and electronic document management systems (e.g., Veeva) • Familiarity with data mining and analysis tools such as Spotfire and Power BI

🏖️ Benefits

• Equal opportunity employer • Less than 10% travel requirement