PV Project Director

Company Description

We are PrimeVigilance (part of Ergomed Group), a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs and Quality Assurance.


PrimeVigilance provides first class support to our small to large pharmaceutical and biotechnology partners maintaining long lasting relationships and has become one of the global leaders in its field. We cover all therapy areas including medical device.


We love investing in our staff by providing an excellent training and development platform. We value employee experience, well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved.


Come and join us in this exciting journey to make a positive impact in patient's lives.


Job Description

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'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
• 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.

Qualifications

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)

Additional Information

Why PrimeVigilance?

We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow.


To succeed we must work together with a human first approach. Why? because our people are our greatest strength leading to our continued success on improving the lives of those around us.


We offer:

• 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

Our core values are key to how we operate, and if you feel they resonate with you then PrimeVigilance could be a great company to join!

• Quality

• Integrity & Trust
• Drive & Passion
• Agility & Responsiveness
• Belonging
• Collaborative Partnerships

We look forward to welcoming your application.