This role requires working and supporting group of Project Managers who lead one or several pharmacovigilance (PV) project teams, performing contracted pharmacovigilance activities on behalf of PrimeVigilance clients.
Role and Responsibilities
- 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.
- Principle functions
- For the Client (may include but is not limited to the following):
- 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鈥檚 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
- As Line Manager
- 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.
- For the Company (may include but is not limited to the following):
Acting as the primary contact point for departmental matters assigned to him/her
- Use and continually develop leadership skills
- Reporting to the Business Unit Lead or Head of Global Project Management department and provide them with a regular update regarding the status of projects, if needed
- Perform project and departmental financial analysis, as needed
- Developing PV controlled documents (SOPs/OGs/Forms) in the field of expertise
- Developing PV training presentations and delivering PV training, as required
- Initiate and support of departmental processes improvements
- Assisting in departmental regulatory inspection preparedness for the company PV system and actively participating the PV inspections or audits
- Support quality and efficiency strategies within the company
- Support the Business/Commercial team during development of contracts and proposals, as applicable.