Project Manager - Pharmacovigilance (Home based in Europe)
- Experience Level
- Experienced (non-manager)
This position is available office based in London or home based in UK, office based in Geneva or home based in Switzerland, home based in Spain, France, Germany, Italy, Netherlands and Norway.
Responsible for leading UBC Pharmacovigilance (PV) project teams to deliver contracted services and ensuring achievement of contracted project milestones for assigned projects.
- Bachelor’s degree or equivalent experience.
- Minimum of 2 year direct project management experience at a Contract Research Organization (CRO) or pharmaceutical company and/ or 4 years of pharmacovigilance experience or equivalent experience.
- Knowledge of global and local PV regulations and legislation, both pre- and post-marketing, preferred.
- Strong project management, interpersonal, verbal and written communication skills, both internally and towards clients.
- Ability to identity, document, track and resolve project action items for multiple programs simultaneously.
- Ability to create, review and revise documentation, processes and procedures as they relate to PV activities, to identify issues/problem areas, assess compliance, and communicates findings to the appropriate team(s) and management.
- Experience with Argus or other industry standard safety database(s)
- Project financial expertise including invoicing, revenue recognition, margin analysis, scope management and resource management.
- Demonstrated supervisory skills preferred.
- Demonstrated independent problem solving and issue resolution track record.
- Excellent interpersonal and client management skills.
- Effective presentation skills.
- Must be flexible and adaptable to quickly changing project priorities
- Must be able to speak fluent English.
- Ability to travel to UBC locations, clients, and professional/scientific meetings.
Matrix supervision of project team(s).
Expected Project Load:
2 to 5 projects (global and local) depending on scope.
Specific Job Duties:
- Manages Pharmacovigilance project(s) as assigned by UBC PV Management per the scope of work and within the contracted budget and timelines.
- Responsible for the overall on time, on-budget delivery of the contracted Scope of Work for assigned projects.
- Oversees all aspects of the PV project conduct from Start-up through Close-Out.
- Responsible for on-time and on-budget delivery of the project
- Serves as UBC primary contact with the client.
- Ensures appropriate project related communication within the project team.
- Leads and coordinates internal project and client teleconferences/meetings.
- Prepares project timelines and project management related deliverables.
- Identity, document, track and resolve project action items for multiple programs simultaneously
- Establishes and manages project communication tools (e.g. project email address, project specific teleconference number, project portal/SharePoint).
- Coordinates development of Project Specific plans to achieve contracted milestones (i.e., Adverse Event Reporting Plan, Periodic Safety reporting Plan).
- Prepares and maintains Project Management Plan.
- Ensures project is conducted in concert with UBC Standard Operating Procedures (SOPs), project-specific procedures and client’s SOPs and, in accordance to the highest quality standards.
- Prepares and keeps the Project team log and project specific training matrix up-to-date.
- Ensures project specific trainings are assigned to relevant project team member as per project specific training matrix.
- Maintains and files project specific training records for the project team.
- Prepares project metrics & Key Performance Indicators (KPI) and monthly metrics reports, as needed.
- Supports Qualified Person Responsible for Pharmacovigilance in Europe (EU QPPV) and local QPPV(s) in his/her activities throughout the project.
- Prepares project specific presentations for client meetings/audits.
- Assists in project specific audit/inspection preparation and actively participate in the audit/inspection.
- Develops and implements Corrective and Preventive Actions (CAPAs) related to Project Management issues as necessary.
- Ensures that project specific CAPAs/SIRs are being closed on time.
- Tracks non-compliance issues occurring in the frame of his/her projects.
- Escalates issues in a timely manner to the PV Director /Associate Director who supervises the project.
- Maintains cumulative list of Actions items for the project including owner, due date, status, etc…
- Reviews contract and project scope to ensure that change orders (CO) are issued as necessary.
- Works with UBC contracts team on CO development and execution.
- Performs project financial oversight (identify percent complete units for monthly revenue recognition meeting with Finance as well as forecast future unit completion).
- Ensure project budget is tracked against contract milestones.
- Oversees project profitability analysis and present findings as requested to Senior PV Management.
- Supports business development initiatives including proposal, slides, attendance at bid defense meetings and proposal and budget development.
- Determines the need for third party vendor services and coordinate vendor management activities
- Other duties as assigned by Senior Management.
United BioSource Corporation (UBC) is a leading provider of pharmaceutical support services, partnering with life science companies to make medicine and medical products safer and more accessible. Our services support the full lifecycle of medicine and medical products, including development, commercialization, and long-term value and safety.
While UBC offers employment within Patient Support, Nursing, Pharmacy and Corporate, two main focus areas for the company are Clinical Development & Research and Safety & Risk Management. Members of the Clinical Development and Research teams help evaluate study protocol, target study population, recruit physicians and patients, and collect, clean, validate and report data. As a result, sponsors are able to submit findings to regulatory authorities or make a no-go decision in a timely and clear-cut manner. Additionally, our Safety and Risk Management teams develop, deliver, and report evidence to reinforce safe and appropriate product use.
Through our Patient Access services, we help patients begin therapy quickly and remain on therapy, building strong relationships with patients to ensure optimal care.
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