Project Manager – Pharmacovigilance

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

📋 Description

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

• Manage assigned pharmacovigilance projects within the agreed scope, budget, and timelines.

• Ensure timely and budget-compliant delivery of the contracted work scope.

• Supervise the execution of pharmacovigilance projects from initiation to completion.

• Act as the primary contact for clients at UBC.

• Organize internal project and client teleconferences and meetings.

• Prepare project timelines, management deliverables, project-specific plans, and Project Management Plans.

• Establish and oversee project communication tools, including project email, teleconference numbers, and project portals/SharePoint.

• Identify, document, monitor, and address project action items across various programs.

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

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

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

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

• Prepare presentations for client meetings and audits.

• Assist in audit and inspection preparation and participation.

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

• Monitor non-compliance issues and escalate them to pharmacovigilance leadership.

• Review project scope and contracts; coordinate change orders with the contracts team.

• Oversee project financial performance, revenue recognition, budget tracking, and profitability analysis.

• Provide support for business development, proposals, bid defense meetings, and budget development.

• Coordinate activities related to third-party vendor management.

• Perform other duties as assigned by Senior Management.

⛳️ Requirements

• Bachelor’s degree or equivalent experience.

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

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

• Strong project management skills along with interpersonal, verbal, and written communication abilities.

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

• Proficient in creating, reviewing, and revising documentation, processes, and procedures related to pharmacovigilance activities.

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

• Project financial expertise including invoicing, revenue recognition, margin analysis, scope management, and resource management.

• Preferred demonstrated supervisory skills.

• Proven ability to independently solve problems and resolve issues effectively.

• Exceptional interpersonal and client management skills.

• Proficient presentation abilities.

• Flexibility and adaptability to changing project priorities.

• Fluent in English is required.

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

🏝️ Benefits

• 6 month Fixed Term Contract.

• Equal opportunity employer committed to fostering a diverse, equitable, and inclusive culture.