Project Manager – Pharmacovigilance

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

📋 Description

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

• Manage designated PV projects while adhering to the scope of work, allocated budgets, and timelines.

• Oversee all facets of PV project execution from initiation to closure.

• Act as UBC’s primary point of contact for clients.

• Organize internal project and client teleconferences and meetings.

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

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

• Coordinate plans for adverse event reporting and periodic safety reporting.

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

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

• Generate project metrics, KPIs, and monthly metrics reports.

• Support EU QPPV and local QPPVs throughout the project lifecycle.

• Prepare presentations for client meetings and audits.

• Assist in audit and inspection preparation and participation.

• Develop and implement CAPAs related to project management challenges.

• Monitor non-compliance issues and escalate them to the supervising PV Director/Associate Director.

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

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

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

• Identify third-party vendor requirements and manage vendor activities.

• Perform additional 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.

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

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

• Capability to identify, document, track, and resolve project action items across multiple programs concurrently.

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

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

• Knowledge of project financials, including invoicing, revenue recognition, margin analysis, scope management, and resource management.

• Demonstrated supervisory skills are preferred.

• Proven independent problem-solving and issue-resolution abilities.

• Exceptional interpersonal and client management skills.

• Strong presentation abilities.

• Flexibility and adaptability to shifting 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 dedicated to fostering a diverse, equitable, and inclusive culture.