Operation Specialist1-sy

IQVIA

Shanghai, China
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.
  • Liaise with different functional team members, e.g. project management, clinical, data management and health care professionals e.g. investigators, medical monitors, site coordinators and designees to address project related issues.

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
  • Quality standards
  • Productivity standards

Nice-to-have

  • Problem solving capabilities
  • Team Player
  • Self-motivated and flexible
  • 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 Safety Database
  • Knowledge of clinical research regulatory requirements
  • Excellent attention to detail and accuracy
  • Maintain high quality standards
  • 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 work independently
  • Ability to multi-task
  • Meet strict deadlines
  • Manage competing priorities
  • Manage changing demands
  • Ability to delegate
  • Receptive to changing process demands
  • Ability to establish and maintain effective communication
  • Ability to work as a Team Player
  • Ensure quality of deliverables
  • Demonstration of IQVIA core values

Work Rights

Not specified

Tailored Resume

Cover Letter