Project Manager – Pharmacovigilance

• Lead UBC Pharmacovigilance project teams to deliver contracted services and achieve project milestones
• Manage assigned PV projects within scope of work, contracted budgets, and timelines
• Oversee all aspects of PV project conduct from start-up through close-out
• Serve as UBC’s primary client contact
• Coordinate internal project and client teleconferences and meetings
• Prepare project timelines, project management deliverables, project-specific plans, and Project Management Plans
• Establish and manage project communication tools, including project email, teleconference numbers, and project portals/SharePoint
• Coordinate adverse event reporting and periodic safety reporting plans
• Ensure compliance with UBC, project-specific, and client SOPs and quality standards
• Maintain project team logs, training matrices, and training records
• Prepare project metrics, KPIs, and monthly metrics reports
• Support EU QPPV and local QPPVs throughout the project
• Prepare client meeting and audit presentations
• Assist with audit and inspection preparation and participation
• Develop and implement CAPAs related to project management issues
• Track non-compliance issues and escalate them to the supervising PV Director/Associate Director
• Review contracts and project scope and coordinate change orders with the contracts team
• Perform project financial oversight, budget tracking, revenue forecasting, and profitability analysis
• Support business development initiatives, proposals, bid defense meetings, and budget development
• Determine third-party vendor needs and coordinate vendor management activities
• Perform other duties assigned by Senior Management

• Bachelor’s degree or equivalent experience
• Minimum of 2 years of direct project management experience at a Contract Research Organization (CRO) or pharmaceutical company and/or 4 years of pharmacovigilance experience or equivalent experience
• Knowledge of global and local PV regulations and legislation, both pre- and post-marketing, preferred
• Strong project management, interpersonal, verbal and written communication skills
• Ability to identify, document, track and resolve project action items for multiple programs simultaneously
• Ability to create, review and revise documentation, processes and procedures related to PV activities
• Experience with Argus or other industry standard safety databases
• Project financial expertise including invoicing, revenue recognition, margin analysis, scope management and resource management
• Demonstrated supervisory skills preferred
• Demonstrated independent problem-solving and issue-resolution track record
• Excellent interpersonal and client management skills
• Effective presentation skills
• Flexibility and adaptability to changing project priorities
• Fluent English required
• Ability to travel to UBC locations, clients, and professional/scientific meetings

• 6 month Fixed Term Contract
• Equal opportunity employer committed to a diverse, equitable and inclusive culture