Associate Director, Drug Safety Operations - Systems Job at Talent Groups, Waltham, MA

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  • Talent Groups
  • Waltham, MA

Job Description

Job Description

We are seeking an Associate Director, PV Systems to manage and enhance its global Argus Safety platform and PV reporting systems. This role will lead end-to-end safety systems activities including configuration, validation, E2B reporting, system integrations, and vendor collaboration. The position partners closely with PV Operations, Regulatory Affairs, Quality, and IT to ensure compliance with global GVP regulations and inspection readiness.

Requirements:

  • Expert-level experience with Argus Safety and RxLogix PV Reports
  • 10+ years in pharmacovigilance safety systems and reporting
  • Strong knowledge of FDA/EMA/ICH E2B and GVP regulations
  • Proven experience with system validation, upgrades, and data migrations
  • Excellent communication, project leadership, and problem-solving skills

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