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Global Provider of Expert, High-Quality Services to the Biopharmaceutical Industry. Your Full-Service Solutions Partner.
PV Project Director
Location
North Carolina
Posted
113 days ago
Salary
0
Seniority
Lead
Job Description
PV Project Director
ERGOMED
• 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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