Senior Director of ICSR

ppMedicine moves forward here. So will you. /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-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. /p pIf 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. /p h3Job Description /h3 pbPOSITION SUMMARY: /bManages ICSR Management Unit for assigned staff and ensures all unit-relevant activities are delivered within agreed extent. Contributes to achieving company´s goals and objectives. Performs project budget reviews, and provides support to, and management of, the Associate Directors, ICSR. Other responsibilities include independent analysis of workload, productivity and utilization of resources and their appropriate redistribution to ensure performance of the highest quality as well as coordination with other departments for all activities related to the ICSR Management Unit. Strong experience in post marketing and clinical processing and staff management required. /p pbRole and Responsibilities: /b /p ul liManaging the assigned ICSR Management Unit effectively /li liEnsuring adequate resources within the ICSR project teams to achieve the maximum level of productivity and utilisation /li liSetting productivity targets for ongoing projects and reviewing proposed target updates as required /li liBased on reports and analyses, defining the appropriate reallocation of resources in ICSR Management Unit, or working with the resourcing unit for reallocation to and from other units and departments /li liManaging Associate Directors and oversight ofall employees to ensure they are adequately utilised and productive and reallocating employees to other ICSR Leads/teams as necessary /li liNotifying the Resourcing department about the need for additional resources for assigned project teams if resources cannot be managed internally and officially opening the requests upon approval and budget confirmations /li liProposing the necessary changes within the project team processes to ICSR leadership /li liFinding solutions and introducing best practices to increase productivity and utilization within the ICSR Management Unit /li liTraining and mentoring of ICSR Line Managers and senior staff. /li liPreparing various analyses and reports /li liReviewing budgets and resource allocations for all new projects and new scope of work for existing projects and supporting Directors of Projects, as applicable /li liSupporting the Business/Commercial team during development of contracts and proposals, as applicable /li liSupporting the Operations and Project Analytics team, as applicable /li liAssisting HR in employee recruitment, performance evaluation, promotion, retention and termination activities /li liReviewing and approving all Critical CAPAs from the ICSR Management Unit /li liReviewing and addressing any requests from Quality department regarding ICSR Management Unit /li liReviewing and updating PrimeVigilance operating procedures and guidelines, as applicable /li /ul h3Qualifications /h3 pbEducation, qualifications and professional memberships: /bLife science graduate, pharmacy, nursing, other healthcare related qualification or experience in pharmacovigilance -Intermediate. /p pbEXPERIENCE: /bExtensive experience in pharmacovigilance case processing including post marketing, clinical and ideally medical devices. Demonstrated leadership experience at a senior level. /p pbSPECIAL SKILLS ( /bAdvanced)b: /b /p ul liExcellent communication (written and verbal) skills /li liExcellent organization skills, including attention to details and multitasking /li liExcellent management skills, including delegation skills, time and issue management /li liTechnical skills /li /ul pbPC SKILLS: /bAdvanced literacy (MS Office) -Advanced: /p h3Additional Information /h3 pWhen 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. /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 the outcome, because someone is waiting on it. /p pAgility and responsiveness: we move quickly, because patients cannot wait. /p pBelonging: everyone is welcome, and every voice counts. /p pCollaborative partnerships: we go further by going together. /p /p #J-18808-Ljbffr