Senior Safety Physician
Senior safety physician needed for a leading life science and pharmaceuticals organisation based in Cambridgeshire who are looking to employ an experienced and well-rounded senior safety physician that takes pride in their work with an in-depth knowledge of the pharmaceutical/ biopharmaceutical industry, especially clinical research and global regulatory requirements (eg BLA, NDA or MAA) and practices governing expedited and periodic safety reporting, signal generation, safety evaluation and risk management activities.
What the role entails:
Some of the main duties of the Senior Safety Physician will include:
- Responsible for the Clinical Safety strategy for assigned AstraZeneca (AZ) 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.
- Responsible for 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)/programs(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, as well as colleagues from all three Science Units as leader/member of a Safety and Strategy Management 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.
What experience you need to be the successful Senior safety physician:
- Medical degree (eg 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 5-7 years of Drug Development/Patient Safety experience (the majority of which should be in industry in Patient Safety) with clear evidence of delivery
- A thorough knowledge of the pharmaceutical/ biopharmaceutical industry, especially clinical research and global regulatory requirements (eg BLA, NDA or MAA) and practices governing expedited and periodic safety reporting, signal generation, safety evaluation and risk management activities
This really is a fantastic opportunity for a Senior Safety Physician to progress their career. If you are interested, please apply as soon as possible as this position will be filled quickly so don't miss out!
Services advertised by Gold Group are those of an Agency and/or an Employment Business.