Project Manager – Pharmacovigilance

🔥 1 minute ago

🔔 Pennsylvania – Remote

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⏳ Contract/Temporary

🟢 Junior

🟡 Mid-level

👷‍♀️ Project Manager

👻 Ghost score 10%

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Logo of UBC

UBC

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.

📋 Description

• Lead UBC Pharmacovigilance project teams to deliver contracted services and achieve project milestones • Manage 2 to 5 global and local projects according to scope, budget, and timelines • Oversee PV project conduct from start-up through close-out • Serve as UBC’s primary client contact and coordinate project communications • Lead internal project and client teleconferences and meetings • Prepare project timelines, management deliverables, presentations, project plans, metrics, KPIs, and monthly reports • Establish and manage project communication tools, including email, teleconference, and SharePoint resources • Coordinate project-specific plans, including 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 • Support EU QPPV and local QPPV activities • Assist with audit and inspection preparation and participation • Develop and implement CAPAs related to project management issues and track their closure • Track and escalate non-compliance and project action items • Review scope and contracts, issue change orders, and coordinate with the contracts team • Provide project financial oversight, budget tracking, profitability analysis, and revenue recognition forecasting • Support business development proposals, budgets, presentations, and bid defense meetings • Determine third-party vendor needs and coordinate vendor management • Perform other duties assigned by Senior Management

🎯 Requirements

• Bachelor’s degree or equivalent experience • Minimum of 2 year 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, both internally and towards clients • 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 • Must be flexible and adaptable to quickly changing project priorities • Must be able to speak fluent English • Ability to travel to UBC locations, clients, and professional/scientific meetings

🏖️ Benefits

• Remote opportunities • Competitive salaries • Growth opportunities for promotion • 401K with company match* • Tuition reimbursement • Discretionary PTO (Paid Time Off) • Paid Holidays • Employee assistance programs • Medical, Dental, and vision coverage • HSA/FSA • Telemedicine (Virtual doctor appointments) • Wellness program • Adoption assistance • Short-term disability • Long term disability • Life insurance • Discount programs

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