Safety Manager And Qppv
Tfs Trial Form Support AB / Biomedicinjobb / Lund
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hela Sverige The Safety Manager is part of the Project Delivery organization and is responsible for management in post-marketing drug safety and will work according to company policies, SOPs and regulatory requirements.ESSENTIAL JOB FUNCTIONSOverall responsibility of the handling of SAEs in clinical trials and spontaneous reports from the market, to ensure collection, assessment and entering into the safety database in accordance with the TFS/clients' SOPs and existing regulatory demandsReview and approval of processed cases, AE/SAE reconciliation and safety codingQPPV responsibilitiesOverview of safety activities in the departmentResponsible for plans/instructions and SOPs for post approval surveillanceOverlook that assigned projects and tasks in the unit are performed in accordance with current routines, methods, SOPs (TFS or client 's) and current legal requirementsLead relevant project groups/meetingsInitiate and lead internal improvement project with other relevant departmentsAct as a Project Lead for Safety-only projectsActively contribute to the organization and development of routines/processes to enhance the work at TFSResponsible for the updates of templates for safety handling in specific studies/projects according to relevant SOPsOversees the validation of computer applications specific for the department with respect to drug safety requirementsEnsure that new processes are implemented within the unitBeing well-informed and updated on regulations, directives and guidelines concerning handling and reporting of SAEs in clinical trials and serious as well as non-serious events from the market (pharmacovigilance) and other safety issues.Line management for staff in the Drug Safety UnitCoach, support and mentor staffResponsible for the education and supervision of new Drug Safety personnelAnnual performance reviews with staff including salary negotiatingApproval of time reports and travel expensesInvoicing/revenue for projects where being a project managerREQUIREMENTSBachelor's Degree, preferably in life science or nursing; or equivalent10 years of relevant experienceAble to work in a fast-paced environment with changing prioritiesUnderstand the medical terminology and science associated with the assigned drugs and therapeutic areasUnderstanding of the Good Clinical Practice regulations, ICH guidelines, Pharmacovigilance legislation and internal SOPsAbility to work independently as well as in a team matrix organization with little or no supervisionExcellent written and verbal communication skillsDemonstrate proficiency using typical word processing; spreadsheets desirable; and presentation software a plusDemonstrate ability to lead, mentor, educate and supervise Drug Safety personnelBENEFITSWhat can we offer you?A great place to work where you will get the chance to push your career to the next level, global environment with global opportunities. You will also get the opportunity to be part of a team with highly intelligent, passionate experts from all over the world. TFS is a place for inspiration where we focus on the patients, saving lives and aiming to increase their quality of life by supporting our clients."
Publiceringsdatum2019-07-26Så ansöker duSista dag att ansöka är 2019-09-30
Klicka på denna länk för att göra din ansökanFöretagTfs Trial Form Support AB
KontorsadressScheelevägen 8 Lgh 1601
Jobbnummer 4847475
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