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, modelling 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. 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.
Qualifications
- Medical degree (e.g. MD, MBBS).
- 2+ years of clinical experience post‑registration, industry experience is preferred.
- High level of medical competence, with an ability to balance this with industry standards to achieve business goals.
- 2+ years of Drug Development/Patient Safety experience (the majority of which should be in industry in Patient Safety) with clear evidence of delivery.
Preferred Education, Experience and Skills
- MSc/PhD in scientific field.
- Ability to work across TAs and Functions.
- Experience leading and inspiring Patient Safety colleagues.
- A demonstrated ability to understand epidemiological data.
Benefits
Competitive salary and benefits package on offer. The successful candidate will have access to a flexible employee benefits fund, including holiday purchase and flexible time off, pension contributions, Share Save Plans, a performance recognition scheme and a competitive, generous remuneration package.
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