Project Manager / Sr Project Manager - Pharmacovigilance

Brief Description :

Responsible for leading UBC Pharmacovigilance (PV) project teams to deliver contracted services and ensuring achievement of contracted project milestones for assigned projects.

Requirements :

• Bachelor’s degree or equivalent experience.
• Minimum of 4 year direct project management experience at a Contract Research Organization (CRO) or pharmaceutical company and / or 6 years of pharmacovigilance 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.

Supervisory Responsibilities :

• Matrix supervision of project team(s).
• Mentors Junior Project Manager(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.
Il y a 20 jours