Safety Specialist / Safety Lead

🔥 0 minutes ago

🇯🇵 Japan – Remote

⏰ Full Time

🟠 Senior

✨ Safety Specialist

👻 Ghost score 20%

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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Precision Medicine Group

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2012

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 $35.2M Venture Round on 2021-03

Consulting • Healthcare • Logistics

Precision Medicine Group is a global team of experts that specializes in precision medicine, which combines advanced lab sciences, translational informatics, regulatory affairs, payer insights, and marketing communications. The company focuses on overcoming product development and commercialization challenges for pharmaceutical and life sciences clients. Their services include biomarker-driven research and development, as well as commercialization support for life science organizations from launch to product maturity. Precision Medicine Group operates through two main arms: Precision for Medicine and Precision AQ, specializing in clinical and commercial solutions respectively.

📋 Description

• Develop safety management plans • Manage serious adverse event (SAE, SUSARS) cases from intake through regulatory reporting • Provide safety expertise to team members, clients, and study site personnel • Interface with sponsors, vendors, and internal team members to design and implement safety collection tools, processes, and reporting systems • Participate in assessment and setup of safety databases for SAE data • Perform intake, triage, data entry, medical coding, expectedness assessment, narrative composition, and similar-event analyses for individual case safety reports (ICSRs) • Perform quality control of documents and safety reports • Prepare and/or review project-specific safety reporting plans and medical coding plans • Prepare and/or review safety training materials • Provide safety training and oversight for consultants, contractors, and/or staff • Review and/or draft standard operating procedures and work instructions • Assist clients and departmental staff with safety-related reviews and other services • Perform other duties as assigned

🎯 Requirements

• BA/BS degree • Minimum 5 years safety experience • Health care professional • Hands on experience with global safety database(s), SAE case processing including narrative writing, and safety reports generation • Working knowledge of MedDRA and WHODrug • Working knowledge of FDA safety regulations, ICH guidelines, and global safety regulations • Nursing or pharmacy degree preferred • Clinical trial safety experience • Hands on experience with Argus • Industry experience in CRO or pharmaceutical company preferred

🏖️ Benefits

• Regular full-time employment • Remote work from Japan