Safety Specialist/Safety Lead

🔥 4 hours ago

🇯🇵 Japan – Remote

⏰ Full Time

🟠 Senior

✨ Safety Specialist

👻 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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Precision For Medicine

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

💰 $75M Private Equity Round on 2015-12

Healthcare • Consulting • Logistics

Precision For Medicine is a leading organization that specializes in supporting the development and commercialization of innovative therapies, particularly in oncology, rare diseases, and autoimmune conditions. With a comprehensive range of services including clinical trial management, lab services, and biospecimen collection, they integrate advanced biomarker capabilities and manufacturing solutions to streamline the complex clinical development processes. Their mission is to accelerate research and bring life-changing medical solutions to patients by overcoming traditional inefficiencies typically found in the pharmaceutical development landscape.

📋 Description

• Develop safety management plans • Manage serious adverse event (SAE, SUSARS) cases from intake through regulatory reporting • Provide timely safety expertise to team members, clients, and study site personnel • Interface with sponsors, vendors, and internal team members to assist with safety collection tools, processes, and reporting systems • Participate in assessment and setup of a safety database to capture SAE data • Perform intake, triage, data entry, medical coding, expectedness assessment, narrative composition, and similar-event analyses for individual case safety reports (ICSRs) • Follow applicable regulations and company policies and procedures • 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 • Clinical trial safety experience • Hands on experience with Argus • Industry experience in CRO or pharmaceutical company

🏖️ Benefits

• Regular full-time employment • Remote work arrangement in Japan