Project Manager – Pharmacovigilance

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

📋 Description

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

• Manage assigned Pharmacovigilance (PV) projects within the defined scope, budgets, and timelines.

• Oversee the conduct of PV projects from initiation to close-out.

• Ensure timely and budget-friendly project delivery.

• Act as UBC’s primary contact for clients.

• Facilitate project-related communication among project teams.

• Lead and organize internal project and client teleconferences and meetings.

• Develop project timelines and management deliverables.

• Identify, document, track, and resolve action items across various programs.

• Establish and maintain project communication tools, including email, teleconference, and SharePoint/project portal.

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

• Prepare and maintain Project Management Plans.

• Ensure adherence to UBC, project-specific, and client Standard Operating Procedures (SOPs) and quality standards.

• Maintain logs, training matrices, and records for the project team.

• Prepare project metrics, Key Performance Indicators (KPIs), and monthly metrics reports.

• Support the EU Qualified Person for Pharmacovigilance (QPPV) and local QPPVs during project activities.

• Prepare presentations for client meetings and audits.

• Assist with audit preparation and participation in inspections.

• Develop and implement Corrective and Preventive Actions (CAPAs) related to project management issues.

• Track non-compliance issues and report them to the supervising PV Director/Associate Director.

• Maintain a comprehensive list of cumulative project action items.

• Review contracts and project scope, issuing change orders as necessary.

• Collaborate with the contracts team on the development and execution of change orders.

• Provide financial oversight for projects, including revenue recognition forecasts and budget tracking.

• Analyze project profitability and present findings to Senior PV Management.

• Support business development efforts, proposals, bid-defense meetings, and budget creation.

• Determine the necessity for third-party vendors and manage vendor-related activities.

• Perform additional duties as assigned by Senior Management.

• Provide matrix supervision of project teams.

• Manage an anticipated load of 2 to 5 global and local projects.

⛳️ Requirements

• Bachelor’s degree or equivalent experience required.

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

• Preferred knowledge of global and local PV regulations and legislation, both pre- and post-marketing.

• Strong skills in project management, interpersonal relations, and both verbal and written communication, internally and with clients.

• Ability to identify, document, track, and resolve project action items across multiple programs simultaneously.

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

• Capability to identify issues or problem areas, assess compliance, and communicate findings to the relevant teams and management.

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

• Expertise in project financial matters including invoicing, revenue recognition, margin analysis, scope management, and resource management.

• Demonstrated supervisory skills preferred.

• Proven track record of independent problem solving and issue resolution.

• Excellent interpersonal and client management abilities.

• Effective presentation skills.

• Flexibility and adaptability to rapidly changing project priorities.

• Fluency in English is required.

• Willingness to travel to UBC locations, client sites, and professional/scientific meetings.

🏝️ Benefits

• Opportunities for remote work.

• Competitive salary packages.

• Opportunities for professional growth and advancement.

• 401K plan with company matching.

• Tuition reimbursement program.

• Discretionary Paid Time Off (PTO).

• Paid holidays.

• Employee assistance programs.

• Medical, dental, and vision insurance coverage.

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

• Telemedicine services (virtual doctor appointments).

• Wellness programs.

• Adoption assistance benefits.

• Short-term and long-term disability coverage.

• Life insurance options.

• Discount programs available.