ERGOMED
Global Provider of Expert, High-Quality Services to the Biopharmaceutical Industry. Your Full-Service Solutions Partner.
PV Project Director
Location
United States
Posted
8 days ago
Salary
Not specified
Bachelor Degree5 yrs expEnglish
Job Description
• 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
• 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
Job 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
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