At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost 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 exceptional skills with those of people from all over the globe.
As a Safety Physician in Gaithersburg, MD, you'll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives. GMD (Global Medicines Development) drives late-stage development of our innovative pipeline, transforming exciting science into valued new medicines and ensuring patients around the world can access them.
AstraZeneca's strategy in CVRM focuses on ways to reduce morbidity, mortality and organ damage by addressing multiple risk factors across cardiovascular (CV), renal and metabolic disease indications. The patient-centric approach is reinforced by science-led life-cycle management programs and technologies, including early research into regenerative methods.
Main Duties and Responsibilities:
You will 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. You will be responsible for 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.
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 and other information sources in order to predict / establish the safety profile of compounds in clinical development, including 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. You will be involved in all safety surveillance activities, that may include: medical review of individual safety cases (providing medical expertise and judgement), signal detection, evaluation and SERM activities (or Medimmune equivalent) for all products in area or responsibility. You will provide medical input and review of periodic reports (e.g. PBRERs, PSURs, or DSURs) and renewal documentation submitted to regulatory agencies. Provides the patient safety contribution to global regulatory submissions (NDA, BLA, MAA etc.) for new products, formulations or indications.
Medical degree (e.g. MD, MBBS).
At least 2 years of clinical experience post-registration.
High level of medical competence, with an ability to balance this with industry standards to achieve business goals.
At least 2 years of Drug Development/Patient Safety experience (the majority of which should be in industry in Patient Safety) with clear evidence of delivery.
MSc/PhD in scientific discipline.
Able to work across TAs and Functions.
Experience of supervising Patient Safety colleagues.
A demonstrated ability to understand epidemiological data
Next Steps - Apply today!
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AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.