Pharmacovigilance Project Director

PrimeVigilance, an Ergomed company, was established in 2008 by former Drug Regulators, 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 or any other drug-related problem (WHO definition of pharmacovigilance). Since then, PrimeVigilance has added other services including medical information call centres, and has grown to become one of the global leaders in its field, providing services to over 150 client companies in more than 100 countries. We continue to expand as we strive to become the leading global pharmacovigilance and medical information service provider. Our Mission is a world with safer drugs.

PrimeVigilance is continuing to expand and is looking for a Director of Projects to join our dynamic and rapidly growing organization.

This role requires working with and managing group of Project Managers who lead one or several pharmacovigilance (PV) project teams. Project teams are performing contracted pharmacovigilance activities on behalf of PrimeVigilance clients.

• Management of a team of Project Managers
• Advising project teams as a PV expert on all contracted activities performed on behalf of PrimeVigilance clients 
• Leading project managers in order 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
• 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
• Overseeing training of project teams, managing and mentoring junior colleagues 
• Participation in client audits and inspections
• Initiate and support of departmental processes improvements
• Support quality and efficiency strategies within the company
• Occasional traveling to different locations (mostly Europe)

Acting as a PM for the most important projects/clients

• Maintaining good client relations, oversight on all issues communication with clients and ensuring a consistently high quality of work for each client
• Oversee management of changes to the project scope, project schedule and project costs, Project set-up and maintenance activities planning
• Making sure invoices are prepared and sent on time
• Review project specific analysis 
• 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
• Ensuring compliance with worldwide PV regulatory obligations; manage the process for Quality Events (QEs) and implement corrective and preventative action (CAPA).
• Ensuring adequate resourcing within your allocated client projects
• Developing PV controlled documents (SOPs/OGs/Forms) in the field of expertise
• Developing PV training presentations and delivering PV training, as required 
• Support the Business/Commercial team during development of contracts and proposals, as applicable

• Life science graduate, pharmacy, nursing or other healthcare related qualification
• Min 5-7 years of appropriate work experience in pharmacovigilance
• Min 2 years of line management experience
• Management skills, including time and issue management
• Leadership skills - ability to motivate/coach people
• Excellent client-facing and internal communication (written and verbal) skills
• Organization skills, including attention to detail and multitasking
• Conflict resolution skills
• Decision making
• English - advanced (spoken, written)
• Advanced literacy (MS Office)

OUR OFFER:

• Dynamic team of colleagues in a fast-growing company
• Multicultural environment, English as a company language
• Various type of clients (originator, generic, small – mid – big size companies, rare diseases drug producers etc.)
• Competitive salary and wide range of benefits
• Strong emphasis on personal and professional growth
• Extensive and specialized trainings in pharmacovigilance – internal trainings provided by skilled professionals, but also prestigious trainings/seminars taking place abroad
• Friendly working environment with several social events per year