Pharmacovigilance Coordinator – Japanese Required
PSI CRO · Buenos Aires
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.
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PSI CRO
Buenos Aires
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