Sr. Project Manager - Drug Safety & PV Systems

Milestone Technologies, Inc. is seeking a Senior Project Manager to support Digital Enterprise Capabilities R&D function by managing three concurrent GxP safety-system initiatives. The role involves project planning, vendor coordination, and stakeholder engagement across various business and technology domains to ensure successful implementation of safety systems.

Responsibilities:

• Manage three equal-priority GxP safety-system initiatives in parallel: Oracle Argus upgrade, RxLogix PV Intake upgrade, and Safety Database Japan implementation
• Establish and maintain integrated project plans, milestones, RAID logs, dependency trackers, decision logs, status reports, and executive-ready updates
• Build and manage an integrated roadmap across all three projects, ensuring cross-project dependencies, vendor activities, QA and validation milestones, launch-readiness activities, and stakeholder decision points are visible and actively managed
• Coordinate with business stakeholders, Drug Safety / Pharmacovigilance SMEs, clinical stakeholders, QA, Validation, Compliance, Security, IT, and vendor teams
• Coordinate vendor project activity, deliverables, meeting cadence, timeline inputs, risks, dependencies, and issue resolution
• Partner with QA and Validation owners to track validation-related dependencies, documentation needs, testing windows, approval milestones, and release-readiness requirements
• Support hybrid Agile-Waterfall delivery, using Agile practices where relevant for software delivery and Waterfall / phase-gate discipline where required for GxP validation and governance
• Prepare project materials for governance forums, steering committees, leadership updates, stakeholder decision meetings, and escalation reviews
• Maintain project information and reporting in company-approved tools such as Clarity, Smartsheet, MS Project, Jira, ServiceNow, SharePoint, Teams, and applicable validation or document-control platforms
• Partner with change-management resources and business stakeholders to support launch readiness, stakeholder communications, adoption planning, training coordination, integration launch, and post-launch stabilization
• Escalate project, vendor, compliance, validation, security, timeline, and dependency risks promptly through the appropriate governance channels

Requirements:

• 8-12+ years of senior project management experience in pharma, biotech, life sciences, or another regulated technology environment
• Demonstrated experience managing GxP systems projects
• Strong experience with pharmacovigilance, drug safety, or safety-system technology environments
• Ability to manage multiple concurrent initiatives with competing priorities and equal business importance
• Conceptual understanding of QA, validation, SDLC, PMLC, and regulated system delivery
• Working knowledge of compliance considerations including 21 CFR Part 11, Annex 11, SOX, data privacy, and information security
• Experience coordinating vendor-led application upgrades, integrations, implementations, or system changes
• Strong stakeholder-management skills across business, technology, QA, validation, compliance, security, and vendor teams
• Strong executive communication and governance reporting capability, including the ability to prepare and present steering committee materials
• Experience using project delivery tools such as Clarity, Smartsheet, MS Project, Jira, ServiceNow, SharePoint, and Teams
• Ability to work remotely from the US Eastern Time Zone and support overlap with Europe, India, and potentially Japan
• Oracle Argus upgrade or implementation experience
• RxLogix PV Intake experience
• Safety database implementation, migration, integration, or regional rollout experience
• Japan or regional safety-system implementation experience
• Clarity proficiency
• Experience supporting launch readiness and change-management coordination
• PMP, Agile, Scrum, or equivalent project-management certification
• Experience presenting to steering committees or executive governance forums