PV Project Director

Role Overview

• Management and support of a team of Project Managers.
• Ensuring that all contracted activities performed on behalf of PrimeVigilance clients are delivered within budget and are on time with good quality and in compliance with the applicable regulatory requirements.
• Support project teams as PV expert on all contracted activities performed on behalf of PrimeVigilance clients, as necessary.
• Providing support to Business Unit Leads, Head of Global PM department and senior leadership management, as applicable, in other activities undertaken on behalf of the client and the company.
• Together with direct reports representing the client's and PrimeVigilance interests with the aim of keeping the agreed project scope
• Oversee management of changes to the project scope, project schedule and project costs, as applicable
• Maintaining good client relations and ensuring a consistently high quality of work for each client
• Being involved in issue escalation process, as applicable
• Understand client PV requirements and ensure service provided addresses all requirements
• Overseeing and monitoring Project set-up and maintenance activities planning; attending client meetings, as required
• Having an overview of deliverables to the clients
• Being involved in tasks to be delivered to the client, as applicable
• Oversight on all issues communication with clients
• Overseeing training of project teams
• Close cooperation with other PrimeVigilance and/or the client’s respective departments making sure contracted activities are delivered with high quality and within set timelines
• Assurance that all Primevigilance departments and respective personnel are familiar with the client and the project scope
• Review of client specific core documents (e.g. Joint operational guidelines, Safety management plan), as applicable
• Making sure invoices are prepared and sent on time
• Review project specific analysis, as needed
• Advising the client as requested or as appropriate in PV matters such as changes in regulations/guidance
• Providing the client with appropriate qualified resources to ensure their project is managed and handled effectively
• Overseeing the management of Quality Management System activities for the client, as required
• Making sure that quality standards applicable to the respective client are met
• Ensuring compliance with worldwide PV regulatory obligations; manage the process for Quality Events (QEs) and implement corrective and preventative action (CAPA).
• Participation in client audits and inspections
• Accountable for performance development and career management of Project Managers
• Manage performance and growth opportunities of Project Managers
• Provide soft skill and technical skill development to grow the PM team talent
• Develop career plan and provide coaching and mentoring.
• Communicate regularly with Project Managers to ensure their knowledge, understanding, and compliance with assigned project goals and departmental and corporate strategies and objectives.
• Support Business Development by assisting with resource planning.
• Engaging and coordinating with other line managers across the Project Management department
• Participate with the PrimeVigilance Senior Leadership Team to determine and operationalize corporate strategies and visions for the continued growth of PrimeVigilance.
• Participate to the development and implementation of recruiting, interviewing, and hiring strategies.
• Conduct new employee orientation and onboarding.
• Participate in project review meetings with senior management to ensure areas of development, training needs and coaching are aligned with the business needs.
• Monitor and/or manage assigned studies as needed according to all applicable SOPs, regulations, and guidelines.
• Assess Project Managers performance and liaise with Director of Projects where required.
• Assist project teams with coordination of study activities to ensure project deliverables meet sponsor deadlines and ensure all objectives and expectations are fulfilled.
• Work with all operational units to help investigate issues and promote effective resolutions.
• Establish strong professional relationships with colleagues by building trust, open communication, and managing day-to day operational issues.
• Provide excellent customer service to both internal and external clients; ensure the same from the Project Managers.
• Review and approve weekly timesheets for PrimeVigilance tasks.
• Review and approve requests from PMs for time off and support Project Management coverage plan.

Requirements

• Life science graduate, pharmacy, nursing or other healthcare-related qualification.
• 5 years of appropriate work experience.
• Excellent client-facing and internal communication (written and verbal) skills
• Organization skills, including attention to detail and multitasking
• Management skills, including time and issue management
• Conflict resolution skills
• Decision making
• Team working
• Ability to motivate/coach people; leadership
• English
• fluent (spoken, written)
• Advanced literacy (MS Office)

Benefits

• Training and career development opportunities internally
• Strong emphasis on personal and professional growth
• Friendly, supportive working environment
• Opportunity to work with colleagues based all over the world, with English as the company language