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Safety Data Management Specialist

Company: Unicon Pharma
Location: Newark
Posted on: May 21, 2020

Job Description:

Job Description: Review, preparation, and completion of reports of adverse drug experiences, to determine the safety profile of clients products and to meet regulatory requirements. Determination of local submission of individual and, where appropriate, aggregate safety reports Carry out case processing activities Review, rank, verify, process and document case-related information: terms; validity, seriousness, special scenarios; timelines; accuracy and consistency. Process cases based on these assessments Review case criteria to determine appropriate workflow for case processing Assess case to distinguish those with particular complexities and/or specific issues, and escalate appropriately Write and edit case narrative Determine and perform appropriate case follow-up, including generation of follow-up requests Review processed cases to verify accuracy, consistency and compliance with process requirements, and review case data for special scenarios Liaise with key partners, locally, and other stakeholders regarding safety data collection and data reconciliation Develop 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 Determine reportability of scheduled reports, ensuring adherence to regulatory requirements Consistently apply regulatory requirements and policies Participate, as appropriate, in local, internal and external safety activities Reports to Country Safety Lead or Safety Team Lead or Safety Officer (depending on local organization and safety group size) Skills: Experience in pharmacovigilance and/or data management preferred but not required Experience and skill with medical writing an advantage Demonstrated computer literacy Experience in use and management of relational databases preferred Additional Requirements: Health care Professional or equivalent experience preferred Ability, with supervison, to solve routine problems and to surface issues constructively Ability to make basic decisions with an understanding of the consequences Ability to achieve personal objectives while meeting departmental standard of performance Ability to work under supervison in a matrix organization Fluency in spoken and written English

Keywords: Unicon Pharma, Newark , Safety Data Management Specialist, Executive , Newark, New Jersey

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