Associate Pharmacovigilance Project Director (Delivery)- Europe

Company Description

Medicine moves forward here. So will you.

At PrimeVigilance, patient safety is not one part of the job. It is why we exist.

We are a global pharmacovigilance specialist. Our teams help clients navigate complex regulations while keeping patient safety at the center of every decision, from early development through to post-marketing surveillance. Increasingly, the value we create is not only in processing safety data but in interpreting it: spotting the signal that matters early and turning it into insight our clients can act on.

That work takes curious minds, problem-solvers and experts who care about getting it right. It also takes a culture worth staying for. Across Europe, North America, South America, Asia and Australia, we work in an environment built on kindness, flexibility, growth and belonging, where colleagues support one another and good ideas are heard wherever they come from.

If you want a role with real purpose, global reach and the chance to keep growing while you help protect patients, you will feel at home here. We would love to hear from you.

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 the company.
• 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.
• 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.