The statements made in this job description are intended to describe the general nature and level of work being performed by those persons assigned to this job. These statements are not intended to be an exhaustive list of all responsibilities, duties and skills required of these people, nor will they necessarily all apply for every individual assigned to this job. The Safety Physician could be working as a Global Safety Physician (GSP).
In addition to the physician accountabilities may also act as SaMT leader on designated products.
Responsible for the Clinical Safety strategy for assigned AstraZeneca-MedImmune 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.
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.
Responsible for continuous efficient evaluation of adverse event and all other safety information in order to predict and manage the safety profile of compounds in clinical development and marketed products through identifying the need for update to reference safety information and drive proactive implementation of risk management initiatives in accordance with global regulatory requirements.
Provides consistent communication of safety topics across all regulatory safety documents, eg Periodic Benefit Risk Evaluation Reports (PBRERs), Periodic Adverse Drug Experience Reports (PADERs) and Development Safety Update Reports (DSURs), for assigned product(s)/program(s).
Proactively evaluates 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.
Works collaboratively with experts from across AZ-MedImmune (e.g. Pre-clinical safety, Safety Knowledge Groups, Safety Informatics Scientists and Safety Science), as well as colleagues from all three Science Units as leader/member of a Safety Management Team)/MedImmune Safety Review Team or as a member of other cross-functional project teams, thereby promoting high quality evaluation of safety data.
Understands the role of the QPPV and contributes to the maintenance of the pharmacovigilance system and processes.
Supports key contacts with opinion leaders, as needed.
NB: It is not mandatory to meet the minimum requirements for length of experience or to have completed the UK Higher Medical Training in Pharmaceutical Medicine; these details are intended to be indicative of the level of knowledge, expertise and recognition required of an individual in this job.