AstraZeneca
Vaccines and Immune Therapies
GlobalPatientSafetyPhysician
“Global Patient Safety Physician at AstraZeneca. Skills: Clinical Safety strategy, Drug Development/Patient Safety experience, Medical expertise. Working with the Safety Team, be responsible for the Clinical Safety strategy for assigned AstraZeneca 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.. Definition of identified and potential risks with high level mi”
What You'll Achieve.
Provide long-lasting immunity to millions of people; Directly impact the lives of populations around the world; Turn our ambition into a reality; Ensure we continue to create a culture of collaboration and teamwork
Industry & Context.
Definition of identified and potential risks with high level mitigation and proposals for mitigation minimisation; Address urgent and important safety issues; Evaluation of signals; Deliver accurate and fit for purpose safety evaluation documents with clear conclusions
Engaging face-to-face in our offices 3 days a week
What They're Looking For.
Must Have
Medical degree (eg MD, MBBS), At least 2 years of clinical experience post-registration, High level of medical competence, At least 2 years of Drug Development/Patient Safety experience (the majority of which should be in industry in Patient Safety) with clear evidence of delivery
Nice to Have
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
What You'll Do.
Working with the Safety Team
be responsible for the Clinical Safety strategy for assigned AstraZeneca 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.
Definition of identified and potential risks with high level mitigation and proposals for mitigation minimisation safety go-no go criteria for the clinical input to TPP/TPC; s safety submission response to regulatory safety queries and definition of the risk component of the benefit/risk assessment.
Provides expertise to the medical content of the safety specification
pharmacovigilance plan and risk minimisation activities in the core PRMP
CPRL and globally reviewed LRMPs.
Represents PS on cross-functional Clinical Teams and/or Project Teams for developmental and/or marketed products.
Provides medical input to ensuring that risk-minimisation strategies are implemented appropriately in relevant documents such as product reference safety information.
Provides strategic clinical safety input into Clinical Development planning activities in accordance with PS Operating Model and Science Unit Service Level agreements.
Provides strategic and medical input to project specific safety requirements (PSSR).
Reviews and provides technical input and approval for investigator brochures
final study reports and external data monitoring committees as appropriate.
Provides input on cross-functional ad-hoc teams set up to address urgent and important safety issues.
May present safety information at clinical investigator and commercial meetings.
Facilitates establishment of a Safety Management Team as necessary.
Provides medical input to regulatory supporting documentation for labelling updates.
Provides medical input into Identification and utilization of appropriate sources of information and database searches to retrieve relevant data for evaluation of signals.
Collaborates with external provider representatives in routine signal management activities.
Discusses the results of data evaluation with the Surveillance Team and/or appropriate key stakeholders
eg Patient Safety VP TA
Provides medical input to deliver accurate and fit for purpose safety evaluation documents with clear conclusions in response to internal or regulatory authority requests for safety data.
Provides strategic input into responses to regulatory requests for local label deviations from the company core safety documentation.
In consultation with the PS scientist and Clinical representatives
prepares the Developmental Core Safety Information (DCSI) for assigned development products.
Provides medical input and review of periodic reports (eg PBRERs
DSURs) and renewal documentation submitted to regulatory agencies.
Provides the patient safety contribution to global regulatory submissions (NDA
MAA etc) for new products
formulations or indications.
How You'll Work.
Team & Collaboration
Working across teams, functions and even the globe; Engaging face-to-face in our offices 3 days a week; Teams come together to strategize, brainstorm and connect on key projects; Represents PS on cross-functional Clinical Teams and/or Project Teams; Provides input on cross-functional ad-hoc teams; Collaborates with external provider representatives; Discusses the results of data evaluation with the Surveillance Team and/or appropriate key stakeholders; In consultation with the PS scientist and Clinical representatives, prepares the Developmental Core Safety Information (DCSI); Investing in ground-breaking collaborations, local partnerships, and commercial initiatives; Team players
Communication Scope
Communication of the strategy at the project team/governance level; May present safety information at clinical investigator and commercial meetings
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