IT Project Manager – Pharmacovigilance

Description

We are seeking an experienced mid-level (5-7 years) IT Project Manager with strong expertise in Life Sciences, Good Practice (GxP) compliance, and Pharmacovigilance (PV) to lead components of a large Patient Safety/PV system replacement effort. 

The successful candidate will manage end-to-end delivery of IT initiatives involving pharmacovigilance systems, safety databases, regulatory reporting platforms, integrations, data migration, process automation, and system enhancements. This role will work closely with business, clinical, drug safety, regulatory affairs, quality, compliance, vendors, and technology teams. 

Requirements

Key Responsibilities: 

• Lead end-to-end IT projects from initiation and planning through implementation, validation, deployment, and post-production support. 
• Manage projects related to: 
• Pharmacovigilance and drug safety systems 
• Safety case processing and adverse event reporting 
• Regulatory submissions and reporting 
• Signal detection and safety surveillance 
• Aggregate reporting, including DSURs, PBRERs, and PSURs 
• Product quality complaints and medical information integrations 
• Safety data warehouses, analytics, and dashboards 
• System integrations, upgrades, migrations, and platform implementations 
• Develop project charters, schedules, budgets, resource plans, risk registers, communication plans, and governance structures. 
• Coordinate cross-functional teams across IT, Pharmacovigilance, Clinical Operations, Regulatory Affairs, Quality Assurance, Medical Affairs, and external vendors. 
• Ensure project deliverables comply with applicable GxP requirements, company policies, and regulatory expectations. 
• Oversee or support Computer System Validation (CSV) activities, including: 
• User requirements specifications 
• Functional and technical specifications 
• Risk assessments 
• Validation plans and protocols 
• Test execution and defect management 
• Traceability matrices 
• Validation summary reports 
• Manage change control, deviations, CAPAs, audit actions, and inspection-related commitments associated with project delivery. 
• Establish and monitor project controls, milestones, dependencies, issues, risks, assumptions, and decisions. 
• Manage vendors, system integrators, contracts, deliverables, service levels, and commercial performance. 
• Facilitate steering committee meetings, working groups, status reviews, and executive reporting. 
• Ensure effective stakeholder communication and timely escalation of project risks and issues. 
• Support data integrity, privacy, security, and compliance requirements for safety and regulated systems. 
• Coordinate user acceptance testing, training, deployment readiness, and organizational change activities. 
• Ensure project documentation is complete, accurate, inspection-ready, and maintained in accordance with the quality management system. 
• Identify opportunities to improve pharmacovigilance processes, system usability, operational efficiency, and data quality. 
• Contribute to portfolio planning, technology roadmaps, budget forecasting, and continuous improvement initiatives. 

Required Qualifications: 

• Bachelor's degree in Information Technology, Computer Science, Life Sciences, Engineering, Business, or a related discipline. 
• Typically 5-7 years of IT project management experience, preferably within the pharmaceutical, biotechnology, medical device, or healthcare industry. 
• Proven experience managing projects involving Pharmacovigilance or drug safety systems. 
• Practical knowledge of GxP-regulated environments and computerized system compliance. 
• Experience with CSV, system implementation, validation, testing, change control, and release management. 
• Strong understanding of project management methodologies, including Waterfall, Agile, or hybrid delivery models. 
• Experience managing cross-functional teams and third-party vendors. 
• Strong understanding of project governance, financial management, risk management, and executive reporting. 
• Excellent written, verbal, analytical, and stakeholder-management skills. 

Preferred Experience: 

• Experience with pharmacovigilance platforms such as: 
• Oracle Argus Safety 
• Veeva Vault Safety 
• ArisGlobal LifeSphere Safety 
• Ennov Pharmacovigilance 
• R&D IT experience 
• Other safety databases or adverse event management platforms 
• Experience with integrations involving: 
• Clinical trial systems 
• Electronic data capture systems 
• Regulatory information management systems 
• Quality management systems 
• Product complaint systems 
• Data warehouses and analytics platforms 
• Knowledge of adverse event case processing, medical review, coding, duplicate detection, reconciliation, reporting, and signal management. 
• Familiarity with regulatory reporting standards and technologies, including E2B(R3), ICSR, XML, and applicable regional reporting requirements. 
• Understanding of FDA, EMA, MHRA, ICH, and other relevant global regulatory expectations. 
• Experience supporting regulatory inspections, internal audits, and vendor audits. 
• Experience with cloud-based platforms, APIs, middleware, data migration, and enterprise architecture. 
• Familiarity with privacy and security requirements, including GDPR and applicable local data protection regulations. 
• Experience with Jira, Microsoft Project, Smartsheet, ServiceNow, Confluence, or similar tools. 
• Project Management Professional (PMP), PRINCE2, Agile, Scrum, or equivalent certification. 
• Training or certification in GxP, CSV, quality systems, or pharmacovigilance is advantageous. 

Core Competencies: 

• IT project and program management 
• Pharmacovigilance and drug safety technology 
• GxP compliance and CSV 
• R&D IT 
• Risk, issue, and dependency management 
• Vendor and contract management 
• Stakeholder engagement and communication (Executive Presence) 
• Business process analysis 
• Data migration and system integration 
• Quality and inspection readiness 
• Change management and organizational adoption 
• Problem-solving and decision-making 
• Leadership without direct authority 

Working Relationships: 

The role will collaborate with: 

• Pharmacovigilance and Drug Safety 
• Medical Affairs 
• Regulatory Affairs 
• Clinical Operations 
• Quality Assurance and Compliance 
• Information Security and Data Privacy 
• Enterprise Architecture and Infrastructure 
• Data and Analytics 
• Procurement and Legal 
• External technology vendors and implementation partners 
• Senior leadership and project steering committees 

Employment Details: 

Job Title: IT Project Manager - Pharmacovigilance and GxP 

Department: Information Technology / R&D Technology 

Reports To: Product Owner, Patient Safety 

Location: Cambridge, MA - on site 5 days per month 

Employment Type: 1-year Contract 

Travel: Occasional travel may be required 

Experience Level: Mid-Level (5-7 years)