Pharmacovigilance Coordinator, Japanese Skills Required

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PSI CRO AG

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1996

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

PSI CRO AG is a global contract research organization (CRO) that specializes in conducting clinical trials. The company focuses on delivering pivotal Phase 2 and 3 clinical trials across various therapeutic areas, including Inflammatory Bowel Diseases, Oncology, Hematology, Infectious Diseases, Multiple Sclerosis, and Rare Diseases. PSI utilizes a proprietary technology platform for clinical trial planning and financial tracking to ensure trials are conducted on time and within budget. The company is recognized for its expertise, quality, compatibility, and reliability, having been awarded the CRO Leadership Awards for multiple consecutive years.

📋 Description

• Provide day-to-day support to the company’s global Pharmacovigilance Department and In-country Clinical Caretaker (ICCC) in clinical trials with the corresponding services • Process and report safety information (including electronic reporting) throughout the course of clinical trials • Help to enhance patient care and safety in relation to the use of novel pharmaceuticals and investigational devices • Collect relevant and reliable medical scientific information • Serve as a contact point for Safety Desk and clinical project teams ensuring appropriate receipt, timely distribution, documentation, and filing of safety reports such as Serious Adverse Events (SAEs) and other Reportable Adverse Events (RAEs) reports • Data entry of safety reports into the safety database • Non-medical review/triage of incoming safety reports • Quality control of data entered in the safety database • Safety queries distribution to sites/ investigators • Maintenance and timely update of the company’s project-specific SAEs distribution lists • Review and timely update of project-specific SAEs trackers maintained by PSI project teams • A literature search conduction in a dedicated Japanese scientific database and article triage • Maintain pharmacovigilance documentation and associated records, ensuring all relevant information remains up to date and appropriately documented

🎯 Requirements

• College or University Degree (Biology, Bioscience, or Pharmacy is preferred) • Full working proficiency in English and Japanese • At least 1-year prior experience in Clinical Research as a Clinical Trial Coordinator or similar clinical operational role • Pharmacovigilance Coordinator, Regulatory specialist, Data Management Specialist or the like will be a plus • Administrative work experience • Experience with safety databases and E2B reporting to regulatory authority in Japan (PMDA) and other regulators is a plus • Organizational and planning skills • Detail-oriented, able to multi-task and work in a fast-paced environment • Communication and collaboration skills • Proficiency in standard MS Office applications (Word, Excel and PowerPoint)

🏖️ Benefits

• Excellent and flexible working conditions • Extensive training and friendly, collegial team • Competitive salary and benefits package • Opportunities for personal and professional growth