Pharmacovigilance Business Analyst

Overview

Remote
Depends on Experience
Full Time
Able to Provide Sponsorship

Skills

Pharmacovigilance
Business Analyst

Job Details

Position Title: Pharmacovigilance Business Analyst

Location: Remote

Duration: 12 plus months contract or Fulltime

Requirements:

  • Bachelor's degree in Statistics, Mathematics, Computer Science, Life Sciences or a related field.
  • Minimum 10+ years of Business Analyst experience is required.
  • Clinical Trial domain expertise, including Study Execution, Site Monitoring, Data Management, and Patient Safety.
  • Exposure to Pharmacovigilance, and Quality and Compliance processes preferred.
  • Experience with SQL and relational databases for data analysis.
  • CSV & GxP documentation knowledge (URS, FRS, validation, audit trails).
  • Familiarity with clinical systems (EDC, eSource, CTMS, eTMF, Regulatory Compliance).
  • Strong communication and stakeholder management skills to lead requirement discussions, demos, and collaboration efforts.
  • Project coordination experience, including timeline management and risk identification.
  • Ability to work independently and as part of a team.
  • Experience in principles of Change Management.

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