Senior Director, Patient Safety Physician Line Manager

hace 1 mes

Barcelona, España AstraZeneca A tiempo completo

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 exceptional skills with those of people from all over the globe.

As a **Senior Director, Patient Safety Physician Line Manager - Oncology** you’ll play a pivotal role in channelling our scientific capabilities to make a positive impact on changing patients’ lives. Oncology R&D global development drives our innovative pipeline, transforming exciting 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 haematological cancers. As well as other tumour types, these are being targeted through four key platforms - immunotherapy, the genetic drivers of cancer and resistance, DNA damage repair, and antibody drug conjugates, underpinned by personalized healthcare and biomarker technologies.

**Main Duties and Responsibilities, what you will be doing**:
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.

The role will involve managing a team of Patient Safety Physicians.

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, modelling 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.

**Essential Requirements**:

- Medical degree (e.g. MD, MBBS).
- Previous clinical experience post-registration.
- High level of medical competence, with an ability to balance this with industry standards to achieve business goals.
- Previous Drug Development/Patient Safety experience (the majority of which should be in industry in Patient Safety) with clear evidence of delivery.
- Previous responsibility managing Patient Safety team(s) as evidenced by successful experience

**Desirable Requirements**:

- 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

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