Company DescriptionMedicine 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 DescriptionEnsuring that all contracted activities performed on behalf of PrimeVigilance clients are deliveredwithin 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 scopeOversee management of changes to the project scope, project schedule and project costs, as applicableMaintaining good client relations and ensuring a consistently high quality of work for each clientBeing involved in issue escalation processUnderstand client PV requirements and ensure service provided addresses all requirementsOverseeing and monitoring Project set-up and maintenance activities planning; attending client meetings, as requiredHaving an overview of deliverables to the clientsBeing involved in tasks to be delivered to the client, as applicableOversight on all issues communication with clientsOverseeing training of project teamsClose cooperation with other PrimeVigilance and/or the client’s respective departments making sure contracted activities are delivered with high quality and within set timelinesAssurance that all Primevigilance departments and respective personnel are familiar with the client and the project scopeReview of client specific core documents (e.g. Joint operational guidelines, Safety management plan,…), as applicableMaking sure invoices are prepared and sent on timeReview project specific analysis, as neededAdvising the client as requested or as appropriate in PV matters such as changes in regulations/guidanceProviding the client with appropriate qualified resources to ensure their project is managed and handled effectivelyOverseeing the management of Quality Management System activities for the client, as requiredMaking sure that quality standards applicable to the respective client are metEnsuring 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 QualificationsRequirements:Excellent client-facing and internal communication (written and verbal) skillsVaried PV experience in a CRO Previous experience within PV Project ManagementOrganization skills, including attention to detail and multitaskingManagement skills, including time and issue managementConflict resolution skillsDecision makingTeam workingAbility to motivate/coach people; leadershipAdditional InformationWhen 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. Show more Show less