.Role: Medical Director Patient Safety PhysicianLocation: Onsite BarcelonaAt 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!As a Medical Director, Patient Safety Physician in Barcelona, you'll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives. Oncology R&D global development drives our innovative pipeline, redefining science into valued new medicines and ensuring patients around the world can access them.AstraZeneca's vision in Oncology is to help patients by redefining the cancer-treatment paradigm, with a broad pipeline of next-generation medicines. Our pipeline is focused principally on four disease areas - breast, ovarian, lung and hematological cancers. As well as other tumor types, these are being targeted through four key platforms - immunotherapy, the genetic drivers of cancer and resistance, DNA damage repair, and antibody drug conjugates. All of this delicious new science is underpinned by personalized healthcare and biomarker technologies.Main Duties and Responsibilities:In this role, you'll be responsible 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. Essentially, the 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 as well as the continuous efficient evaluation of adverse event and all other safety information will be within the remit and scope of this role.You will provide 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).You will proactively evaluate the clinical implications of safety data from pre-clinical studies, clinical studies, literature to predict / establish the safety profile of compounds in clinical development. This process includes employing expert groups and methodologies such as Safety Knowledge Groups (SKG's), Safety Science, Informatics expertise, modeling and simulation to manage the risk to patients. Additionally, you'll be involved in all safety surveillance activities, that may include: medical review of individual safety cases (providing medical expertise and judgment), signal detection, evaluation and SERM activities for all products in area of responsibility
