Pharmacovigilance Coordinator, Japanese Skills Required

This is a fully remote position, open to applicants in Peru.

📋 Description

• Provide daily assistance to the company’s global Pharmacovigilance Department and In-country Clinical Caretaker (ICCC) during clinical trials, along with the associated services.

• Process and report safety information (including electronic reporting) throughout the duration of the clinical trials.

• Contribute to improving patient care and safety concerning the use of new pharmaceuticals and investigational devices, gathering pertinent and reliable medical scientific information.

• Act as a liaison for the 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).

• Enter safety reports into the safety database.

• Conduct non-medical review/triage of incoming safety reports.

• Perform quality control of data entered into the safety database.

• Distribute safety queries to sites/investigators.

• Maintain and promptly update the company’s project-specific SAEs distribution lists.

• Review and timely update project-specific SAEs trackers maintained by PSI project teams.

• Conduct literature searches in a dedicated Japanese scientific database and triage articles.

• Keep pharmacovigilance documentation and associated records up to date and properly documented.

⛳️ Requirements

• A College or University Degree (a preference for Biology, Bioscience, or Pharmacy).

• Full working proficiency in both English and Japanese.

• A minimum of 1 year of prior experience in Clinical Research as a Clinical Trial Coordinator or a similar clinical operational role, including experience as a Pharmacovigilance Coordinator, Regulatory Specialist, or Data Management Specialist, is advantageous.

• Previous administrative work experience.

• Familiarity with safety databases and E2B reporting to regulatory authorities in Japan (PMDA) and other regulators is a plus.

• Strong organizational and planning skills.

• Detail-oriented, capable of multitasking, and able to thrive in a fast-paced environment.

• Proficiency in standard MS Office applications (Word, Excel, and PowerPoint).

🏝️ Benefits

• Excellent and flexible working conditions.

• Comprehensive training and a friendly, collegial team.

• Competitive salary and benefits package.

• Opportunities for personal and professional development.