Project Manager - Pharmacovigilance

About this role

As a pharmaceutical support industry leader, UBC is devoted to empowering health solutions for a better tomorrow. We take pride in improvingpatient outcomes and advancing healthcare.At UBCwe provide services to enhance the entire drug development process and commercialization lifecycle - From clinical trial support to real-world evidence generation.

Embark on a rewarding career journey with UBC!Grow your career while making a meaningful impacton the world around you. UBC fosters a culture built on our Core Values being: Collaborative, Conscientious, Curious, Consultative, and Compassionate. We believe in an inclusive workplace that fosters creativity.

If you are seeking a career that will challenge, inspire, and reward you, join us at UBC!

****This opportunity is for a 6 month Fixed Term Contract****

Job Title:

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 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.

Supervisory Responsibilities:

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…