ph3Associate Pharmacovigilance Project Director (Delivery)- Europe /h3 ul liFull-time /li liDepartment: Project Management /li /ul pMedicine moves forward here. So willyou. /p pAt PrimeVigilance, patient safety is not one part of the job. It is why we exist. /p pWe 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. /p pThat work takes curious minds, problem-solversand experts who care about getting it right. It also takes a culture worth staying for. Across Europe, North America, South America,Asiaand Australia, we work in an environment built on kindness, flexibility, growth and belonging, where colleagues support one another andgood ideasare heard wherever they come from. /p pIf you want a role with real purpose, globalreachand the chance to keep growing while you help protect patients, you will feel at home here. We would love to hear from you. /p ul liEnsuring that all contracted activities performed on behalf of PrimeVigilance clients are delivered /li liwithin budget, and are on time with good quality and in compliance with the applicable regulatory requirements. /li liSupport project teams as PV expert on all contracted activities performed on behalf of PrimeVigilance clients, as necessary. /li liProviding 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.



/li liTogether with direct reports representing the client's and PrimeVigilance interests with the aimof keeping the agreed project scope /li liOversee management of changes to the project scope, project schedule and project costs, as applicable /li liMaintaining good client relations and ensuring a consistently high quality of work for each client /li liBeing involved in issue escalation process /li liUnderstand client PV requirements and ensure service provided addresses all requirements /li liOverseeing and monitoring Project set-up and maintenance activities planning; attending client meetings, as required /li liHaving an overview of deliverables to the clients /li liBeing involved in tasks to be delivered to the client, as applicable /li liOversight on all issues communication with clients /li liOverseeing training of project teams /li liClose cooperation with other PrimeVigilance and/or the client's respective departments making sure contracted activities are delivered with high quality and within set timelines /li liAssurance that all Primevigilance departments and respective personnel are familiar with the client and the project scope /li liReview of client specific core documents (e.g. Joint operational guidelines, Safety management plan,…), as applicable /li liMaking sure invoices are prepared and sent on time /li liReview project specific analysis,



as needed /li liAdvising the client as requested or as appropriate in PV matters such as changes in regulations/guidance /li liProviding the client with appropriate qualified resources to ensure their project is managed and handled effectively /li liOverseeing the management of Quality Management System activities for the client, as required /li liMaking sure that quality standards applicable to the respective client are met /li liEnsuring compliance with worldwide PV regulatory obligations; manage the process for Quality Events (QEs) and implement corrective and preventative action (CAPA). /li liParticipation in client audits and inspections /li /ul pRequirements: /p ul liExcellent client-facing and internal communication (written and verbal) skills /li liVaried PV experience in a CRO /li liPrevious experience within PV Project Management /li liOrganization skills, including attention to detail and multitasking /li liManagement skills, including time and issue management /li liDecision making /li liAbility to motivate/coach people; leadership /li /ul pWhen you join Ergomed Group, you make a difference by helping to bring safe and effective pharmaceutical treatment to patients around the world.You'lljoin a passionate and collaborative team of experts in clinical research, pharmacovigilance, and quality consulting. /p pWe 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. /p pQuality:we hold ourselves to the standard patients deserve. /p pIntegrity and trust:we do the right thing, especially when it is hard. /p pDrive and passion:we care about theoutcome, becausesomeone is waitingonit. /p pAgility and responsiveness:we movequickly, becausepatients cannot wait. /p pBelonging:everyone is welcome, and every voice counts. /p pCollaborative partnerships:we go further by going together. /p pWe look forward to welcoming your application. /p /p #J-18808-Ljbffr

📌 Associate Pharmacovigilance Project Director (Delivery)- Europe (Roma)
🏢 Prime Vigilance
📍 Roma