Associate Safety Physician
6 days left
- Experience Level
- Experienced (non-manager)
At AstraZeneca, we make a difference every day by delivering life-changing medicines to millions of people globally. Our purpose is ambitious and so is our approach. Creating a more agile and inclusive environment means building an inspiring culture where we celebrate innovative thinking.
Our Patient Safety team sits within the Chief Medical Office; an integrated, enterprise-wide organisation dedicated to defining the benefit/risk assessment of our medicines across the life-cycle, acquiring and maintaining health authority approvals around the world. Our oncology pipeline, which includes novel combinations and modalities, provides a unique intellectual opportunity for Patient Safety staff. Our teams' experience develops as our portfolio does!
As the Associate Safety Physician and in collaboration with more senior safety physicians you have a role in ensuring the safety of patients who take AstraZeneca medicines. This role is responsible for continuous evaluation of adverse events and other safety information in order to predict and manage the safety profile of drugs throughout their lifecycle. This might include updates to product safety information, along with the design and implementation of risk management initiatives.
Activities are likely to include, but are not limited to:
- Safety surveillance activities, including medical review of individual safety cases, safety signal detection and evaluation for your products, including collaboration with external safety teams.
- Evaluate safety data from pre-clinical and clinical studies, medical literature and other information sources, to characterise the safety profile of AstraZeneca medicines.
- Build and develop clear, concise documents to describe your safety evaluation; for discussion with business partners and to support product labelling updates or responses to regulatory agency requests.
- Medical review for aggregate periodic regulatory reports, such as the Periodic Benefit Risk Report
- Representing Patient Safety on cross-functional teams, including the need to provide input to address urgent and important safety issues.
- Provide patient safety contribution to global regulatory submissions for new medicines, formulations or indications.
- Medical degree (eg MD, MBBS)
- Some clinical experience post-registration
- High level of medical competence, with an ability to balance this with industry standards to achieve business goals
- Intellectual curiosity and proven ability to learn new skills
- Ability to contribute successfully to teams
- MSc/PhD in scientific field
- Some Drug Development/Patient Safety experience
- Experience of supervising Patient Safety colleagues
- A demonstrated ability to understand epidemiological data