Safety Data Management Specialist

divh2Safety Data Management Specialist/h2pJob Responsibilities:/pulliReview, preparation, and completion of reports of adverse drug experiences, to determine the safety profile of Clients products and to meet regulatory requirements./liliDetermination of local submission of individual and, where appropriate, aggregate safety reports/liliCarry out case processing activities/liliReview, rank, verify, process and document case-related information: ENT terms; validity, seriousness, special scenarios; timelines; accuracy and consistency./liliProcess cases based on these assessments/liliReview case criteria to determine appropriate workflow for case processing/liliAssess case to distinguish those with particular complexities and/or specific issues, and escalate appropriately/liliWrite and edit case narrative/liliDetermine and perform appropriate case follow-up, including generation of follow-up requests/liliReview processed cases to verify accuracy, consistency and compliance with process requirements, and review case data for special scenarios/liliLiaise with key partners, locally, and other stakeholders regarding safety data collection and data reconciliation/liliDevelop and maintain expertise and knowledge for applicable corporate and global regulations, for guidelines, Standard Operating Procedures, for data entry conventions, and for search functions in the safety database/liliDetermine report ability of scheduled reports, ensuring adherence to regulatory requirements/liliConsistently apply regulatory requirements and Clients policies/liliParticipate, as appropriate, in local, internal and external safety activities/li/ulpReports to Country Safety Lead or Safety Team Lead or Safety Officer (depending on local organization and safety group size)/ppWhat is the minimum education experience required?:/pulliHealth care Professional or equivalent experience preferred/liliAbility, with supervision, to solve routine problems and to surface issues constructively/liliAbility to make basic decisions with an understanding of the consequences/liliAbility to achieve personal objectives while meeting departmental standard of performance/liliAbility to work under supervision in a matrix organization/liliFluency in spoken and written English/li/ulpAdditional Skills:/pulliExperience in Pharmacovigilance and/ or data management preferred but not required/liliExperience and skill with medical writing an advantage/liliDemonstrated computer literacy/liliExperience in use and management of relational databases preferred/li/ulpAll your information will be kept confidential according to EEO guidelines./p/div