
1001 - 5000 employees
Founded 2003
🏥 Healthcare
💼 Consulting
🧬 Biotechnology
Healthcare • Consulting • Biotechnology
UBC is a company dedicated to improving patient outcomes by connecting specialty therapies to patients in need. They provide modern and customized solutions focusing on access, safety, and evidence generation for biopharmaceutical products. UBC specializes in evidence development, risk management, and patient access, utilizing real-world data and innovative technologies to optimize the healthcare journey and ensure effective medication use.
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1001 - 5000 employees
Founded 2003
🏥 Healthcare
💼 Consulting
🧬 Biotechnology
Healthcare • Consulting • Biotechnology
UBC is a company dedicated to improving patient outcomes by connecting specialty therapies to patients in need. They provide modern and customized solutions focusing on access, safety, and evidence generation for biopharmaceutical products. UBC specializes in evidence development, risk management, and patient access, utilizing real-world data and innovative technologies to optimize the healthcare journey and ensure effective medication use.
• 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
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