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Clinical Safety Coordinator

2+ years
Not Disclosed
10 Oct. 23, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Drug Safety Coordinator/Safety Specialist

Job Summary
We are currently seeking a full-time, office-based Drug Safety Coordinator/Safety Specialist to join our Clinical Safety department in Tokyo, Japan. This position focuses on the handling and processing of adverse events from all sources, including clinical trials and post-marketing surveillance.

Responsibilities

  • Determine action plans for incoming calls related to adverse events.

  • Collect, process, and track incoming events efficiently.

  • Write detailed safety narratives.

  • Report on various safety data metrics.

  • Collaborate with internal departments and investigative clinical research sites to ensure compliance with safety processes.

Qualifications

  • Bachelor’s of Science in Nursing.

  • At least one year of clinical experience; clinical research or post-marketing pharmacovigilance experience is preferred.

  • Proficient in Microsoft® Office.

  • Broad knowledge of medical terminology.

  • Strong organizational and communication skills.

  • Bilingual in Japanese and English.

Medpace Overview

Medpace is a full-service clinical contract research organization (CRO) providing Phase I-IV clinical development services to the biotechnology, pharmaceutical, and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through a scientific and disciplined approach, leveraging local regulatory and therapeutic expertise across major areas including oncology, cardiology, and more.

Why Medpace?

Join Medpace to be part of a team dedicated to positively impacting the lives of patients and families facing various diseases. Our work over the past 30+ years has made a significant difference, and we continue to strive for advancements in healthcare.

Medpace Perks

  • Hybrid work-from-home options (dependent on position and level).

  • Competitive PTO packages.

  • Company-sponsored employee appreciation events.

  • Employee health and wellness initiatives.

  • Flexible work schedules.

  • Competitive compensation and benefits package.

  • Structured career paths with opportunities for professional growth.

Awards

  • Recognized by Forbes as one of America's Best Mid-size Companies in 2021, 2022, and 2023.

  • Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility.