Medical Director Patient Safety Physician
2 weeks ago
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. Making sure work born in a lab can make a real difference. 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 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 safety information review committee activities for all products in area of responsibility. This role will also require your medical input and review of periodic reports (e.g. PBRERs, PSURs, or DSURs) and renewal documentation submitted to regulatory agencies and the patient safety contribution to global regulatory submissions (NDA, BLA, MAA etc.) for new products, formulations or indications. Essential Education, Experience and Skill Requirements
- 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.
- Ability to work effectively in an advanced matrix structure
- Proficient in written and verbal English
- MSc/PhD in scientific field
- Drug Development/Patient Safety work experience from pharmaceutical or biotech industry with clear evidence of delivery.
- A demonstrated ability to understand epidemiological data
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