Pharmacovigilance Coordinator (Japanese Skills Required)

PSI CRO; Ventanilla; Presencial; PEN 135.000 - 237.000; Jornada completa

Descripción de la vacante

PSI CRO is seeking a knowledgeable Pharmacovigilance Coordinator to support its global PV group and in-country operations. The role includes handling safety reports, data entry, and QA across trials, with a focus on timely processing and regulatory compliance.

The successful candidate will have a biology/pharmacy-related degree, strong English and Japanese, and at least one year in clinical research or related operational roles, plus solid MS Office skills.

Formación

• College or University Degree in Biology, Bioscience or Pharmacy.
• Full working proficiency in English and Japanese.
• At least 1 year in Clinical Research as a Clinical Trial Coordinator or similar role.
• Administrative work experience.
• Experience with safety databases and E2B reporting is a plus.

Responsabilidades

• Serve as contact point for safety desk and project teams for SAEs and RAEs.
• Data entry of safety reports into the safety database.
• Non-medical review/triage of incoming safety reports.
• Quality control of data in the safety database.
• Safety queries distribution to sites/investigators.
• Maintain SAEs distribution lists and trackers.
• Literature search and article triage in a dedicated database.
• Maintain pharmacovigilance documentation and records.

Conocimientos

English proficiency

Japanese proficiency

Organizational skills

Detail-oriented

Communication skills

MS Office proficiency

Educación

Biology/Bioscience/Pharmacy degree

Herramientas

E2B reporting systems

Safety databases

Descripción del empleo

PSI is a leading Contract Research Organization with more than 30 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.

We are looking for a knowledgeable and proactive Pharmacovigilance Coordinator to join our enthusiastic and vibrant team.

In this role, you will 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. You will process and report safety information (including electronic reporting) throughout the course of the clinical trials.You will 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.

The scope of responsibilities will include:

• 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.

• College or University Degree (Biology,Bioscience, or Pharmacy is preferred)
• Full working proficiency in Englishand 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)

We offer:

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

If you feel it is time to make your skills and knowledge visible within a growing company with true focus on its people, then PSI is the right choice for you.