Operations Specialist 1

IQVIA UK

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 under guidance and support of senior operation team members

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 under guidance and support of senior operation team members.
  • 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. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world.

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 under guidance and support of senior operation team members.

Skills & Requirements

Must-have

  • Process Safety data
  • Pharmacovigilance activities
  • database entry
  • coding AE and Products
  • writing narratives
  • Literature related activities
  • quality standards
  • productivity and delivery standards
  • compliance to all project related processes
  • IQVIA standard operating procedures
  • customer SOPs
  • training execution and documentation
  • case creation, maintenance, tracking
  • quality problem identification
  • problem solving capabilities
  • liaise with different functional team members
  • liaise with client
  • attend project team meetings
  • IQVIA core values

Nice-to-have

  • mentoring new team members
  • lead/support department initiatives
  • flexibility to operate in shifts
  • willingness 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
  • Self-motivated and flexible
  • Ability to follow instructions/guidelines
  • utilize initiative and work independently
  • Ability to multi-task
  • meet strict deadlines
  • manage competing priorities
  • changing demands
  • Ability to delegate to less experienced team members
  • Ability to be flexible and receptive to changing process demands
  • Ability to establish and maintain effective communication and working relationships
  • Ability to work as a Team Player
  • contribute and work towards achieving Team goals
  • Ensure quality of deliverables

Work Rights

Not specified

Tailored Resume

Cover Letter