Job Description

- 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 thecompany.
- Together with direct reports representing the client's and PrimeVigilance interests with the aimof 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
- 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

📌 Associate Pharmacovigilance Project Director (Delivery)- Europe (Madrid)
🏢 Primevigilance
📍 Madrid