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

Location(s):

• Greater Boston, MA

If you are open to explore and learn more about this opportunity submit your resume using the button below or send directly to DanFarina@JuntoHLS.com.