Associate Pharmacovigilance Project Director (Delivery)- Europe

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.

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

Requirements:

Excellent client-facing and internal communication (written and verbal) skills

Varied PV experience in a CRO

Previous experience within PV Project Management

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

When you join Ergomed Group, you make a difference by helping to bring safe and effective pharmaceutical treatment to patients around the world. You’ll join a passionate and collaborative team of experts in clinical research, pharmacovigilance, and quality consulting.

We are diverse in many ways, yet our values unite us. Our values are how we work, not words on a wall. If they sound like you, you will feel at home here.

Quality: we hold ourselves to the standard patients deserve.

Integrity and trust: we do the right thing, especially when it is hard.

Drive and passion: we care about the outcome, because someone is waiting on it.

Agility and responsiveness: we move quickly, because patients cannot wait.

Belonging: everyone is welcome, and every voice counts.

Collaborative partnerships: we go further by going together.

We look forward to welcoming your application.