Clinical Safety Specialist

2 semanas atrás


Lisbon, Portugal Cencora Tempo inteiro

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply todayJob Details Pharmacovigilance Team Support Data entry and QC of Individual Case Safety Reports (ICSR) of adverse drug reactions deriving from clinical trials, spontaneous reporting systems and the literature; reporting of ICSRs to the competent authorities Support in the generation, processing, documenting, and tracking of follow-up requests Perform L2A and MLM for relevant clients Screening and documentation of scientific global and local literature regarding safety relevant publications Follow up calls to patients or health care professionals and documentation of calls within trackers or the safety database Monitoring of incoming email for multiple programs Regulatory submissions of Individual Case Safety Reports and /or to partners Perform reconciliation with clients and applicable partners Complete monthly/quarterly metrics and KPIs in excel spreadsheets Support the Program Manager or Workstream Lead with all necessary information related to the specific project/program, as needed. .PSMF maintenance Participate and help prepare for audits or inspection Prepare deviations concerning SCS practice area Assist with administrative tasks in the creation of periodic reports PSURs (Periodic Safety Update Reports), DSURs (Development Safety Update Reports), PADERs (Periodic Adverse Drug Experience Reports), risk management plans and signal detection reports The employee agrees to take over primary listed tasks and responsibilities in other service lines, project management activities as client contact point and additional reasonable tasks that align with their abilities, qualification and training, if required.  What Cencora offers​Benefit offerings outside the US may vary by country and will be aligned to local market practice. The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements.Full timeAffiliated CompaniesAffiliated Companies: PharmaLex Portugal Unipessoal Lda (= Pharsolution Lda)


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