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PS Associate Support

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POST DATE 9/15/2016
END DATE 10/29/2016

AstraZeneca Pharmaceuticals LP Wilmington, DE

Wilmington, DE
AJE Ref #
Job Classification
Full Time
Job Type
Company Ref #
Entry Level (0 - 2 years)


Provides support, guidance, and/or technical assistance on a variety of Pharmacovigilance activities across the US region. Applies a range of analytical processes and reporting tools and uses relevant software to support projects. Provides solutions to a variety of technical problems of moderate scope and complexity. br br Accountabilities/Responsibilities br * Conducts activities and interactions consistent with Company values and in compliance with the Code of Conduct and supporting Policies and Standards relevant to your role. Completes all required training on the AZ Code of Conduct and supporting Policies and Standards on time. Reports potential issues of non-compliance. br * Conducts a wide range of Patient Safety processes on an individual basis working within established timeframes ensuring compliance with global and local procedures, policies, processes. br * Coordinates the timely collection of reasons for late adverse event reporting and corrective actions to prevent future late reporting from clinical, regulatory and marketing for inclusion in safety reports to regulatory authorities. br * Demonstrates working knowledge and compliance with AstraZeneca global and local procedural documents and local implementation of Patient Safety objectives, policies, processes and procedures and FDA regulations relevant to Patient Safety and adverse event reporting, including periodic safety reporting. br * Supports regulatory inspections and internal audits. br * Maintains well-documented files for training records, process reviews and investigations, etc. to meet internal and external requirements. br * Executes special database queries to prepare additional reports required by FDA for inclusion in US PADER (Periodic Adverse Drug Experience Report) submissions, and coordinates with other Regional Patient Safety groups to ensure that all report-related documents are acceptable for submissions to regulatory authorities. br * Reviews safety data output for accuracy and completeness prior to submission to internal and external sources. br * Continuously builds upon own knowledge of best practices and new relevant developments current by learning from more senior colleagues. br * Reviews working practices and ensures non-compliant processes are escalated. br * Contributes to the implementation of new safety-related systems, processes and procedures within the US to improve efficiency and productivity. br * Supports the development and execution of user acceptance test scripts per company SOPs to confirm the functionality of Patient Safety applications. br * Effectively coordinates, manages and delivers multiple assignments with competing timelines. br * Participates in cross-functional project team meetings to provide guidance to contributors of documents for submission to regulatory authorities. br * Maintains local internal compliance and external reporting schedules. br * Conducts application training in both classroom setting and individualized setting. br * Maintains knowledge of the Company disease and therapeutic areas for marketed drugs and drugs in development. br * Supports a performance-driven culture. br br