Pharmacovigilance Manager

Brief Description The Senior Project Manager will support the client's Pharmaceuticals Digital Enterprise Capabilities R&D function by managing three concurrent, high‑visibility GxP safety‑system initiatives: Oracle Argus upgrade, RxLogix PV Intake upgrade, and Safety Database Japan implementation. All three initiatives are equal priority and require disciplined project planning, vendor coordination, stakeholder engagement, roadmap integration, governance reporting, risk management, and launch readiness across business, technology, QA, validation, security, compliance, and vendor stakeholders. The ideal candidate is a senior project manager with strong GxP safety‑systems experience, conceptual knowledge of regulated systems delivery, and the ability to operate effectively in a hybrid Agile‑Waterfall environment. The position is best suited for a pure Senior Project Manager with enough program‑management discipline to own an integrated roadmap across multiple related safety‑system initiatives. The role does not require ownership of budget management and is expected to have little to no direct financial tracking responsibility. Primary 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 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. Required Knowledge, Skills, And Experience 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. Preferred Knowledge, Skills, And Experience 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. Project and portfolio management Clarity preferred; Smartsheet and MS Project required or strongly expected. Agile / delivery tracking Service and access workflow ServiceNow familiarity expected. Collaboration and documentation Sharepoint and Teams familiarity expected. #J-18808-Ljbffr Milestone Technologies, Inc.