Operations Specialist 1

IQVIA

Tokyo, Japan
Process safety data
Pharmacovigilance activities
Database entry
Review, assess and process Safety data and information, across service lines, received from various sources and distribute reports/data onwards to both internal and external third parties following applicable regulations Standard Operating Procedures (SOPs) and internal guidelines

Job Summary

  • Review, assess and process Safety data and information, across service lines, received from various sources and distribute reports/data onwards to both internal and external third parties following applicable regulations Standard Operating Procedures (SOPs) and internal guidelines.
  • Perform Pharmacovigilance activities per project requirement including but not limited to, collecting and tracking incoming - Adverse Events(AE)/endpoint information, determining initial/update status of incoming events, database entry, coding AE and Products, writing narratives, Literature related activities as per internal/ project timelines.
  • IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry, pushing the boundaries of human science and data science to make the biggest impact possible.

Matching Summary

Review, assess and process Safety data and information, across service lines, received from various sources and distribute reports/data onwards to both internal and external third parties following applicable regulations Standard Operating Procedures (SOPs) and internal guidelines.

Skills & Requirements

Must-have

  • Process Safety data
  • Pharmacovigilance activities
  • database entry
  • coding AE and Products
  • writing narratives
  • Literature related activities
  • maintain high quality standards

Nice-to-have

  • demonstrate problem solving capabilities
  • establish and maintain effective communication
  • work towards achieving Team goals
  • Self-motivated and flexible
  • Willingness and aptitude to learn new skills

Key Requirements

  • High School Diploma or equivalent
  • Bachelor's degree in life sciences or related field
  • up to 3 years of relevant experience
  • up to 1 year of Pharmacovigilance experience
  • Good knowledge of medical terminology
  • Working knowledge of applicable Safety Database
  • Knowledge of applicable global, regional, local clinical research regulatory requirements
  • Excellent attention to detail and accuracy
  • Good working knowledge of Microsoft Office
  • Strong organizational skills
  • Strong time management skills
  • Strong verbal/written communication skills
  • Ability to follow instructions/guidelines
  • Ability to multi-task
  • Ability to meet strict deadlines
  • Ability to manage competing priorities
  • Ability to work as a Team Player

Work Rights

Not specified

Tailored Resume

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