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Wilmington, Delaware, United States
Job reference: R-007843
Posted date: Jun. 14, 2017

Patient Safety Associate – Wilmington, DE

At AstraZeneca we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. We’re focused on the potential of science to address the unmet needs of patients around the world. We commit to those areas where we think we can really change the course of medicine and bring big new ideas to life. As a Patient Safety Associate – US Medical Affairs, you’ll play a pivotal role in channelling our scientific capabilities to make a positive impact on changing patients’ lives. North American Commercial is the ‘face’ of AstraZeneca and MedImmune to our many healthcare clients. They represent many of the most well recognised and respected products in the industry, and build strong relationships with healthcare professionals.

Main Duties and Responsibilities

The Patient Safety Associate conducts a wide range of pharmacovigilance activities of minimal to sometimes moderate scope and complexity on an individual basis working within established timeframes ensuring compliance with global and local procedures, policies, and processes. The person in this role coordinates the collection of reasons for late adverse event reporting, conducts root cause analysis, corrective actions to prevent future late reporting, and trending analyses from clinical, regulatory and marketing and any other appropriate stakeholders for inclusion in safety reports to regulatory authorities within established timelines. The Associate also contributes to the development, improvement and validation of procedures, policies, processes, guidelines and/or systems for the pharmacovigilance components of various activities and ensures they are compliant with AstraZeneca standards and ensures non-compliant processes are escalated.

Additionally, this role executes special database queries to prepare additional reports required by the FDA for inclusion in US periodic safety report submissions, and coordinates with other regional Patient Safety groups to ensure that all systems-related documents are acceptable for submission to regulatory agencies, as well as contributes to the pharmacovigilance component of contracts/agreements with third parties to ensure quality and integrity of agreement.

Essential Requirements

  • Qualified to degree level in biosciences or an appropriate healthcare, IS/IT or pharmaceutical industry background.
  • 1-2 years’ experience in the pharmaceutical industry, with experience (with drug safety regulations (i.e., FDA, EMA, MHRA, etc.).
    • Experience with Windows Operating system, MS applications (e.g. PowerPoint, Excel, Word, and Internet Explorer) required.
    • Experience with Business Objects, desirable.
    • Experience, running user acceptance test scripts, experience in preparing reporting data, demonstrated problem solving and organizational skills.
  • Knowledge of any relevant legislation/ developments in the area of pharmacovigilance.
  • Basic competence with medical and therapeutic terminology.
Patient Safety Associate
Clinical Development

AstraZeneca in the U.S.

Our North America Commercial Headquarters are in Wilmington, DE, and one of our three core global R&D centers is in Gaithersburg, MD. Gaithersburg is also home to MedImmune, the global biologics research and development arm of AstraZeneca. We have a number of other R&D, manufacturing and office locations across the country.

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  • Clinical Development, Wilmington, Delaware, United StatesRemove