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Pharmacovigilance Coordinator – Japanese Required

PSI CRO · Buenos Aires

Nuevo
🇬🇧 English
Safety databases E2B reporting

Descripcion del puesto

About the role

We are seeking a proactive Pharmacovigilance Coordinator to support our global Pharmacovigilance Department and In‑country Clinical Caretaker team. The role involves processing safety information and enhancing patient safety for clinical trials.

Key responsibilities

  • Act as the primary contact for Safety Desk and clinical project teams, ensuring timely receipt, distribution, documentation, and filing of safety reports such as SAEs and RAEs.
  • Enter safety reports into the safety database, perform non‑medical triage, and conduct quality control of entered data.
  • Distribute safety queries to sites/investigators and maintain project‑specific SAE distribution lists and trackers.
  • Conduct literature searches in Japanese scientific databases and triage relevant articles.

Required profile

  • College or University degree, preferably in Biology, Bioscience, or Pharmacy.
  • Full professional proficiency in English and Japanese.
  • At least one year of experience in clinical research, clinical trial coordination, pharmacovigilance, regulatory affairs, or data management.

Required skills

  • Experience with safety databases and E2B reporting to regulatory authorities.
  • Proficiency in MS Office applications (Word, Excel, PowerPoint).

What we offer

  • Flexible working conditions and extensive training.
  • Competitive salary and benefits package with opportunities for personal and professional growth.

Questions fréquentes

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PSI CRO

Buenos Aires