Project Manager – Pharmacovigilance

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

📋 Description

• Direct UBC Pharmacovigilance project teams to deliver on contracted services and meet project milestones.

• Oversee assigned PV projects ensuring adherence to contracted scope, budget, and timelines.

• Supervise all facets of PV project execution from initiation to completion.

• Act as the primary client liaison for UBC.

• Organize internal project and client teleconferences and meetings.

• Develop project timelines, management deliverables, and specific project plans.

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

• Establish and manage project communication tools, including email, teleconferencing, and SharePoint/project portals.

• Create and maintain Project Management Plans, team logs, training matrices, training records, metrics, and KPI reports.

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

• Assist EU QPPV and local QPPV activities throughout the project lifecycle.

• Prepare materials for client meetings and audits; support audit and inspection prep and participation.

• Develop and execute CAPAs, ensuring timely closure of CAPAs/SIRs.

• Monitor non-compliance issues and escalate them to PV leadership as necessary.

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

• Conduct project financial oversight, budget tracking, revenue forecasting, and profitability analysis.

• Support business development proposals, bid defense meetings, and budget formulation.

• Coordinate activities related to third-party vendor management.

• Perform additional responsibilities as assigned by Senior Management.

⛳️ Requirements

• Bachelor's degree or equivalent experience.

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

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

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

• Ability to identify, document, monitor, and resolve project action items for multiple programs concurrently.

• Capability to create, review, and revise documentation, processes, and procedures related to PV activities.

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

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

• Demonstrated supervisory skills are preferred.

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

• Excellent interpersonal and client management abilities.

• Effective presentation skills.

• Flexibility and adaptability to shifting project priorities.

• Fluent in English.

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

🏝️ Benefits

• 6 month Fixed Term Contract.

• Equal opportunity employer.

• A diverse, equitable, and inclusive culture that promotes respect.