Manager, Global Safety Submissions

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🔥 0 minutes ago

🇧🇷 Brazil – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

👔 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

• Execute strategies and processes for monitoring and submitting individual case safety reports and aggregate safety reports • Assist in producing and reviewing submission compliance metrics for ICSR and aggregate report submissions • Analyze submission metrics and trends and provide data-driven strategic recommendations to the Global Safety Submissions lead • Collaborate with Global Patient Safety, Clinical, and Regulatory functions to ensure compliance with global safety reporting obligations • Assist in developing and reviewing safety exchange agreements/plans with third-party vendors and business partners • Collaborate with the BeiGene Safety Systems team to ensure the global safety database supports submission processes • Support and assist with oversight of CROs involved in safety reporting to local regulatory authorities, ethics committees, and investigators • Assist in developing and training department-specific SOPs and work instructions • Support pharmacovigilance regulatory inspections and partner audits

🎯 Requirements

• Fluent English is required • Pharmaceutical/Biotech industry experience preferred • Bachelor’s Degree with 5 years relevant experience OR Master’s Degree or above (such as RN, RPh, PharmD) with 4 years relevant experience • At least 2 years of drug safety/pharmacovigilance experience preferred • Advanced degree preferred • Strong understanding of global regulatory requirements, including ICH, GVP, FDA 21CFR312.32, 314.80, GCP, NMPA Announcement No. 66 (2018), and PAL of PRC (Dec 2019) • Knowledge of safety reporting regulations for clinical development and post-marketed products • Strong attention to detail and ability to multitask in a fast-paced environment • Strong interpersonal and communication skills • Ability to work individually, within cross-functional teams, and with external partners, vendors, and overseas colleagues • Excellent verbal and written communication skills • Clear and confident presentation skills • Ability to network and partner within global organizations • Results-oriented approach • Proficiency with safety databases and other required platforms and tools • Proficiency with Microsoft Office Suite, including Word, Excel, PowerPoint, and Visio

🏖️ Benefits

• Full-time employment • Remote work arrangement in Brazil