Project Manager - Pharmacovigilance

UBC provides pharmaceutical and clinical research services across the drug development and commercialization lifecycle. The Project Manager, Pharmacovigilance leads PV project teams and manages delivery of contracted services, milestones, budgets, timelines, client communications, and project quality.

Responsibilities

• 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

Preferred

• Knowledge of global and local PV regulations and legislation, both pre- and post-marketing, preferred
• Demonstrated supervisory skills preferred
• Global PV Regulations
• Local PV Regulations
• Pre-Marketing PV
• Post-Marketing PV
• PV Legislation
• Supervisory Skills

Benefits

• Remote opportunities
• Growth opportunities for promotion
• 401K with company match
• Tuition reimbursement
• Discretionary PTO (Paid Time Off)
• Paid Holidays
• Employee assistance programs
• Medical, Dental, and vision coverage
• HSA/FSA
• Telemedicine (Virtual doctor appointments)
• Wellness program
• Adoption assistance
• Short-term disability
• Long term disability
• Life insurance
• Discount programs

Company

• Biopharma evidence development and patient access solutions
• Bethesda, Maryland, USA
• http://ubc.com/
• Founded in 2003
• 1001-5000 employees

Qualifications

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

Required skills

• Argus, Client Management, Pharmacovigilance Regulations, Project Financial Management

Preferred skills

• Demonstrated supervisory skills preferred

Experience

• 2+ years