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Pharmacovigilance & Medical Information Specialist

Lieu Varsovie, Voïvodie de Mazovie, Pologne Job ID R-141863 Date de publication 07/05/2022

At AstraZeneca, we are united by a common purpose: to push the boundaries of science to deliver life-changing medicines. Every day, we make a difference by delivering potentially life-changing medicines to millions of people worldwide. Our purpose is results-oriented and so is our approach. Becoming a more agile and creative company means building a dynamic, inspiring culture where we celebrate diverse, bold thinking, are curious, creative, and open to new insights and ways of working.

Currently we are looking for a Pharmacovigilance & Medical Information Specialist who provides advanced technical assistance on preparing lifecycle management of Patient Safety Enablement processes and technologies which meet the project objectives and local regulatory guidelines. 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.

Typical Accountabilities

  • Reviews summary safety documents for accuracy, completeness and validity prior to regulatory submission
  • Prepares Safety Surveillance Reports, regulatory summary reports, and other customised reports required to support safety surveillance activities
  • Evaluates safety data requests from internal and external sources
  • Works with safety surveillance personnel to prioritise requests, then obtains data directly or requests formal programmatic data queries
  • Supports Patient Safety Medical Director in data review and/or table presentation for formal regulatory submissions or ad hoc safety requests
  • Supports Team Leader in preparation of data for Safety Surveillance Group meetings

Education, Qualifications, Skills and Experience

  • Bachelor’s degree in science/healthcare-related field
  • Sound understanding of principles and concepts within own specialist area
  • Demonstrated knowledge of domestic and global regulations relevant to patient safety
  • Basic understanding of pharmacology, including drug interactions
  • Ability to comprehend and analyze pharmaceutical literature
  • Demonstrated capabilities in project management

Join AstraZeneca and help us deliver life-changing medicines. Be among our employees who continue to make us an innovation-driven company that stands firmly among the world’s leaders in biopharmaceuticals. APPLY!

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.

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