Project Manager – Pharmacovigilance

🔥 0 minutes 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 assigned PV projects within contracted scope, budgets, and timelines • Oversee PV project conduct from start-up through close-out • Deliver projects on time and on budget • Serve as UBC’s primary client contact • Ensure project-related communication within project teams • Lead and coordinate internal project and client teleconferences and meetings • Prepare project timelines and project-management deliverables • Identify, document, track, and resolve action items across multiple programs • Establish and manage project communication tools, including email, teleconference, and project portal/SharePoint • Coordinate project-specific plans to achieve contracted milestones, including adverse-event and periodic-safety reporting plans • Prepare and maintain Project Management 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 the EU QPPV and local QPPVs throughout project activities • 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 • Maintain cumulative project action-item lists • Review contracts and project scope and issue change orders as needed • Collaborate with the contracts team on change-order development and execution • Provide project financial oversight, including revenue recognition forecasts and budget tracking • Oversee project profitability analysis and present findings to Senior PV Management • Support business-development initiatives, proposals, bid-defense meetings, and budget development • Determine the need for third-party vendors and coordinate vendor-management activities • Perform other duties assigned by Senior Management • Provide matrix supervision of project teams • Manage an expected load of 2 to 5 global and local projects

🎯 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 • Ability to identify issues/problem areas, assess compliance, and communicate findings to the appropriate teams and management • 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 quickly changing project priorities • 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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