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Safety Data Management Specialist

Integrated Resources, Inc

Peapack-Gladstone, New Jersey

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JOB DETAILS
JOB TYPE
Contractor
SKILLS
Customer/Client Research, Data Collection, Data Entry, Data Management, Database Administration, Healthcare, Maintain Compliance, Matrix Management, Medical Writing, Pharmacovigilance, Presentation/Verbal Skills, Problem Solving Skills, Regulations, Regulatory Compliance, Regulatory Requirements, Relational Databases (RDBMS), Schedule Development, Standard Operating Procedures (SOP), Team Lead/Manager, Workflow Analysis
LOCATION
Peapack-Gladstone, New Jersey
POSTED
Today
Safety Data Management SpecialistJob Responsibilities:Review, preparation, and completion of reports of adverse drug experiences, to determine the safety profile of Client's products and to meet regulatory requirements.Determination of local submission of individual and, where appropriate, aggregate safety reportsCarry out case processing activitiesReview, rank, verify, process and document case-related information: ENT terms; validity, seriousness, special scenarios; timelines; accuracy and consistency.Process cases based on these assessmentsReview case criteria to determine appropriate workflow for case processingAssess case to distinguish those with particular complexities and/or specific issues, and escalate appropriatelyWrite and edit case narrativeDetermine and perform appropriate case follow-up, including generation of follow-up requestsReview processed cases to verify accuracy, consistency and compliance with process requirements, and review case data for special scenariosLiaise with key partners, locally, and other stakeholders regarding safety data collection and data reconciliationDevelop 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 databaseDetermine report ability of scheduled reports, ensuring adherence to regulatory requirementsConsistently apply regulatory requirements and Client's policiesParticipate, as appropriate, in local, internal and external safety activitiesReports to Country Safety Lead or Safety Team Lead or Safety Officer (depending on local organization and safety group size)What is the minimum education experience required?:Health care Professional or equivalent experience preferredAbility, with supervision, to solve routine problems and to surface issues constructivelyAbility to make basic decisions with an understanding of the consequencesAbility to achieve personal objectives while meeting departmental standard of performanceAbility to work under supervision in a matrix organizationFluency in spoken and written EnglishAdditional Skills:Experience in Pharmacovigilance and/ or data management preferred but not requiredExperience and skill with medical writing an advantageDemonstrated computer literacyExperience in use and management of relational databases preferredAll your information will be kept confidential according to EEO guidelines.

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Integrated Resources, Inc

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