Job DescriptionWe 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 databaseNon-medical review/triage of incoming safety reportsQuality control of data entered in the safety databaseSafety queries distribution to sites/ investigatorsMaintenance and timely update of the company's project-specific SAEs distribution listsReview and timely update of project-specific SAEs trackers maintained by PSI project teamsA 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.QualificationsCollege 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 plusAdministrative work experienceExperience with safety databases and E2B reporting to regulatory authority in Japan (PMDA) and other regulators is a plusOrganizational and planning skillsDetail-oriented, able to multi-task and work in a fast-paced environmentCommunication and collaboration skillsProficiency in standard MS Office applications (Word, Excel and PowerPoint)Additional InformationWe offer:Excellent and versátil working conditionsExtensive training and friendly, collegial teamCompetitive salary and benefits packageOpportunities for personal and professional growthIf 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.

📌 Pharmacovigilance Coordinator (Japanese Skills Required) (Buenos Aires)
🏢 Psi Cro
📍 Buenos Aires