Pharmacovigilance Coordinator, Japanese Skills Required

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

📋 Description

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

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

• Contribute to the improvement of patient care and safety concerning the utilization of innovative pharmaceuticals and investigational devices.

• Gather pertinent and reliable medical scientific information.

• Act as a liaison for the Safety Desk and clinical project teams, ensuring proper receipt, timely distribution, documentation, and filing of safety reports, including Serious Adverse Events (SAEs) and other Reportable Adverse Events (RAEs).

• Enter safety report data into the safety database.

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

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

• Distribute safety queries to sites/investigators.

• Maintain and update the company's project-specific SAEs distribution lists in a timely manner.

• Review and promptly update project-specific SAEs trackers managed by PSI project teams.

• Conduct literature searches in a specialized Japanese scientific database and perform article triage.

• Maintain pharmacovigilance documentation and related records, ensuring that all relevant information is current and accurately documented.

⛳️ Requirements

• A College or University Degree (preferably in Biology, Bioscience, or Pharmacy).

• Proficiency in both English and Japanese at a full working level.

• A minimum of 1-year prior experience in Clinical Research as a Clinical Trial Coordinator or in a similar clinical operational position.

• Experience as a Pharmacovigilance Coordinator, Regulatory Specialist, Data Management Specialist, or similar roles will be an advantage.

• Prior 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 thriving in a fast-paced environment.

• Excellent communication and collaboration abilities.

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

🏝️ Benefits

• Exceptional and flexible working conditions.

• Comprehensive training within a friendly and supportive team.

• Competitive salary and benefits package.

• Opportunities for both personal and professional development.