Pharmacovigilance Coordinator (Japanese Skills Required)

Psi CRO; Lima Metropolitana; Híbrido; PEN 54.000 - 90.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Flexible working conditions

Extensive training

Growth opportunities

Descripción de la vacante

PSI CRO is seeking a Pharmacovigilance Coordinator with Japanese language skills to support the global PV department and ICCC in clinical trials. You will process safety information, manage SAEs/RAEs, and ensure timely reporting across trials.

The role requires English and Japanese proficiency, 1+ year in a clinical research/Pharmacovigilance-related role, and experience with safety databases and E2B reporting is a plus. Peru-based, full-time position with competitive package.

Formación

• Proven ability to manage pharmacovigilance activities and safety reporting.
• Excellent written and verbal communication in English and Japanese.
• Experience with safety databases and E2B reporting is a plus.

Responsabilidades

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

Conocimientos

English proficiency

Japanese proficiency

Pharmacovigilance experience

Safety database experience

Communication skills

MS Office

Educación

Biology/Bioscience/Pharmacy degree

Descripción del empleo

Pharmacovigilance Coordinator (Japanese Skills Required)

• Full-time

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 Coordinatorto 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 reportsinto 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
• 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 workin 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.