Project Manager – Pharmacovigilance

This is a fully remote position, open to applicants in Pennsylvania.

📋 Description

• Lead project teams at UBC Pharmacovigilance to fulfill contracted services and reach project milestones.

• Oversee the management of 2 to 5 global and local projects, ensuring adherence to scope, budget, and timelines.

• Supervise the entire PV project process from initiation to completion.

• Act as the primary client liaison for UBC, facilitating project communications.

• Conduct internal project meetings and client teleconferences.

• Create project timelines, management deliverables, presentations, project plans, metrics, KPIs, and monthly reports.

• Set up and manage project communication tools such as email, teleconferencing, and SharePoint resources.

• Coordinate project-specific strategies, including adverse event reporting and periodic safety reporting plans.

• Ensure adherence to UBC, project-specific, and client SOPs and quality standards.

• Maintain logs for project teams, training matrices, and training records.

• Support activities related to the EU QPPV and local QPPV.

• Assist in preparation for audits and inspections and participate in them as needed.

• Develop and implement Corrective and Preventive Actions (CAPAs) for project management issues and monitor their resolution.

• Track and escalate instances of non-compliance as well as project action items.

• Review project scope and contracts, issue change orders, and liaise with the contracts team.

• Provide oversight on project finances, including budget tracking, profitability analysis, and revenue recognition forecasting.

• Assist in business development efforts, including proposals, budgets, presentations, and bid defense meetings.

• Identify the needs for third-party vendors and manage vendor coordination.

• Undertake additional responsibilities as assigned by Senior Management.

⛳️ Requirements

• Bachelor’s degree or equivalent experience required.

• At least 2 years of direct project management experience in a Contract Research Organization (CRO) or pharmaceutical company, or 4 years of pharmacovigilance experience or equivalent.

• Familiarity with global and local PV regulations and legislation, both pre- and post-marketing, is preferred.

• Strong project management, interpersonal, and communication skills, both verbal and written, with internal teams and clients.

• Capability to identify, document, track, and resolve action items for multiple projects simultaneously.

• Proficiency in creating, reviewing, and revising documentation, processes, and procedures related to PV activities.

• Experience with Argus or other industry-standard safety databases.

• Financial expertise related to projects, including invoicing, revenue recognition, margin analysis, scope management, and resource management.

• Demonstrated supervisory skills are preferred.

• Proven ability to independently solve problems and resolve issues.

• Excellent interpersonal and client management capabilities.

• Strong presentation skills.

• Must be adaptable and flexible in response to rapidly changing project priorities.

• Fluent English proficiency is required.

• Willingness to travel to UBC locations, clients, and professional or scientific meetings.

🏝️ Benefits

• Remote work opportunities.

• Competitive salary packages.

• Opportunities for career advancement.

• 401K plan with company matching.*

• Tuition reimbursement options.

• Discretionary Paid Time Off (PTO).

• Paid holidays.

• Employee assistance programs.

• Comprehensive medical, dental, and vision coverage.

• Health Savings Account (HSA) and Flexible Spending Account (FSA).

• Telemedicine services (virtual doctor appointments).

• Wellness programs.

• Adoption assistance.

• Short-term disability coverage.

• Long-term disability coverage.

• Life insurance options.

• Discount programs available.