Project Manager - Pharmacovigilance

United Biosource Corporation•All Virtual Locations, Home Based Position, USA, Remote, US, PA

13h•Remote

About The Position

The Project Manager, Pharmacovigilance leads UBC Pharmacovigilance project teams to deliver contracted services and achieve project milestones. The role manages assigned projects within their contracted scope, budgets, and timelines, overseeing PV project conduct from start-up through close-out. The Project Manager serves as UBC’s primary client contact, coordinates communication and meetings, develops project plans and timelines, and monitors quality, compliance, finances, resources, and project performance. This opportunity is a six-month fixed-term contract, with an expected workload of two to five global and local projects depending on scope. The position provides matrix supervision of project teams and may require travel to UBC locations, clients, and professional or scientific meetings.

Requirements

Bachelor’s degree or equivalent experience.
At least two years of direct project-management experience at a Contract Research Organization (CRO) or pharmaceutical company, and/or four years of pharmacovigilance experience or equivalent experience.
Strong project-management, interpersonal, verbal, and written communication skills, including communication with clients.
Ability to identify, document, track, and resolve action items across multiple programs simultaneously.
Ability to create, review, and revise documentation, processes, and procedures related to PV activities; identify issues, assess compliance, and communicate findings to appropriate teams and management.
Experience with Argus or another industry-standard safety database.
Project financial expertise, including invoicing, revenue recognition, margin analysis, scope management, and resource management.
Demonstrated independent problem-solving and issue-resolution ability.
Excellent interpersonal and client-management skills.
Effective presentation skills.
Flexibility and adaptability to changing project priorities.
Fluent English speaking ability.
Ability to travel to UBC locations, clients, and professional or scientific meetings.

Nice To Haves

Knowledge of global and local pharmacovigilance regulations and legislation, both pre-marketing and post-marketing.
Demonstrated supervisory skills.

Responsibilities

Manage assigned pharmacovigilance projects according to the scope of work and within contracted budgets and timelines.
Ensure on-time, on-budget delivery of the contracted scope of work and oversee project conduct from start-up through close-out.
Serve as UBC’s primary contact with clients and ensure appropriate communication within project teams.
Lead and coordinate internal project and client teleconferences and meetings.
Prepare project timelines and project-management deliverables, including Project Management Plans.
Identify, document, track, and resolve project action items across multiple programs.
Establish and manage project communication tools, such as project email addresses, teleconference numbers, and project portals or SharePoint sites.
Coordinate development of project-specific plans to achieve contracted milestones, including adverse-event reporting and periodic safety reporting plans.
Ensure project work follows UBC standard operating procedures, project-specific procedures, client procedures, and applicable quality standards.
Maintain project team logs, training matrices, and project-specific training records; ensure relevant training is assigned.
Prepare project metrics, key performance indicators, and monthly metrics reports as needed.
Support the EU Qualified Person Responsible for Pharmacovigilance and local QPPVs in their project activities.
Prepare project-specific presentations for client meetings and audits, and assist with audit and inspection preparation and participation.
Develop and implement corrective and preventive actions related to project-management issues and ensure project-specific CAPAs and SIRs are closed on time.
Track project non-compliance issues and escalate issues promptly to the supervising PV Director or Associate Director.
Maintain a cumulative project action-item list, including owners, due dates, and status.
Review contracts and project scope to determine when change orders are needed, and work with the contracts team on their development and execution.
Provide project financial oversight, including identifying completion units for monthly revenue recognition and forecasting future unit completion.
Track project budgets against contract milestones, oversee profitability analysis, and present findings to Senior PV Management as requested.
Support business development through proposals, slides, bid-defense meetings, and proposal and budget development.
Determine the need for third-party vendor services and coordinate vendor-management activities.
Perform other duties as assigned by Senior Management.