(Jxk-881) - My706 - Medical Director Patient Safety Physician

At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people's outstanding skills with those of people from all over the globe. AstraZeneca's vision is to help patients by redefining the treatment paradigm, with a broad pipeline of next-generation medicines. We're investing to enhance our understanding of disease as we work towards creating the next generation of therapeutics and pioneering new approaches to better predict clinical outcomes. We harness digital, data science & AI to fast-forward our research. Working here means every day, you will be impacting patients' lives across the world.As a Medical Director, Patient Safety Physician in Patient Safety BioPharma, you'll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives. BioPharma Global R&D drives our innovative pipeline, redefining science into valued new medicines and ensuring patients around the world can access them.Main Duties and ResponsibilitiesResponsible for the Clinical Safety strategy for assigned drug projects and products throughout all stages of development and/or when on the market, including implementation and communication of the strategy at the project team/governance level.Continued safety assessment, evaluation, and risk management of AZ products or product groups in various stages of clinical development and/or the post-marketing setting.Efficient evaluation of adverse events and all other safety information.Consistent communication of safety topics across all regulatory safety documents, e.g., Periodic Benefit Risk Evaluation Reports (PBRERs), Periodic Adverse Drug Experience Reports (PADERs), and Development Safety Update Reports (DSURs), for assigned product(s)/program(s).Proactively evaluate the clinical implications of safety data from pre-clinical studies, clinical studies, and literature to predict/establish the safety profile of compounds in clinical development.Employ expert groups and methodologies such as Safety Knowledge Groups (SKGs), Safety Science, Informatics expertise, modeling, and simulation to manage the risk to patients.Involved in all safety surveillance activities, including medical review of individual safety cases, signal detection, evaluation, and safety information review committee activities for all products in area of responsibility.Provide medical input and review of periodic reports.
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