Associate Director, Global PV System Configuration

Junto HLS has been engaged by Leadership at a Top 20 pharma to recruit an Associate Director, Global PV System Configuration.

*** This position requires a mixture of functional and PV systems capabilities and will collaborate with IT, PV and Regulatory stakeholders ***

Position Overview:

  • Oversee the business use and functionality of the global safety database to ensure compliance with PV business and regulatory requirements
  • Execute PV business systems roadmap projects and implementation in coordination with IT
  • Ensure the integrity of all data created, modified, stored, or transmitted by applicable system(s)
  • Strategize and plan for PV systems enhancements/projects in support of global business initiatives and regulatory requirements
  • Drive PV business requirements in collaboration with IT, PV, Regulatory, other stakeholders for application configuration requirements,  designs and debugging for new products, new licenses , studies, reporting rules, E2B profiles , code list changes in console, enhancements, MedDRA up versioning , system upgrades, workflow functionality, and validations
  • Lead E2B program expansion based on business needs and interpretation of global regulatory changes
  • Oversee user acceptance testing for PV Systems projects and activities
  • Lead and maintain user access, products, studies, licenses, code lists system configuration to ensure global reporting compliance
  • Responsible for Change Control Board for ISIS Governance
  • Responsible for vendor management activities
  • Oversee and lead the PV business requirements for database integration and data transfer from business partners
  • Communications across the company regarding strategies, activities and intentions, system planned and unplanned outages, business continuity
  • Develop and ensure delivery of relevant safety system SOPs and training
  • Provide support to PV Systems regulatory inspection and internal audits
  • Maintain global database documentation


    • Greater Boston, MA

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