PrimeVigilance, an Ergomed brand, was established to provide specialised pharmacovigilance services to pharmaceutical and biotechnology companies. These services cover the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects.

Ergomed Plc is a public company on the London stock exchange with its HQ in Guildford, UK.  The company boasted 40% growth in its revenues in its last report.

This success is due to the hard work of our highly skilled employees and our subsequent reputation for excellence with our clients. 

The Project Director (PD) is responsible for the mentoring and supervision of assigned Project Managers, performing contracted pharmacovigilance activities on behalf of PrimeVigilance clients.

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 Head of PM department, Head of PV Operations 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

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

·           To line manage junior colleagues, as applicable

·           Reporting to the (Senior) Director of Projects and/or Head of Project Management department and/or Head of PV Operations and provide them with a regular update regarding the status of projects, if needed

·           Ensuring adequate resourcing within your allocated client projects

·           Perform project and departmental analysis, as needed

·           Training and mentoring of other more junior employees in the field of expertise

·           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

• Education: Life science graduate, pharmacy, nursing or other healthcare related qualification
• Experience: 5-7 years of appropriate work experience
• Special Skills:

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

• Language Skills: English - advanced (spoken, written)
• PC Skills: Advanced literacy (MS Office)

All your information will be kept confidential according to EEO guidelines.

Our Offer:

• Work within a successful, highly – qualified and dynamic team
• Professional training and career development in a fast-growing healthcare company