Global Patient Safety Physician

AstraZeneca•Mississauga, ON

4d•Hybrid

About The Position

At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and even the globe. Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. Our head office and BlueSky Hub in downtown Toronto are purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects. Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work. We know the health of the people, the planet and our business are interconnected which is why we’re taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention. Join us at AstraZeneca in the Vaccines and Immune Therapies therapeutic area as a Global Patient Safety Physician. This role is pivotal in our mission to provide long-lasting immunity to millions of people and directly impact the lives of populations around the world. We are at an exciting frontier of medicine, and we need your expertise to help us turn our ambition into a reality.

Requirements

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 Haves

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

Responsibilities

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.
Activities include, but are not limited to: definition of identified and potential risks with high level mitigation and minimisation; proposals for mitigation minimisation measures; safety go-no go criteria for the clinical programme; input to TPP/TPC; s safety submission strategies; 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, dRMP, 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, protocols, informed consents, 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, QPPV/Deputy QPPV.
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, PSURs, DSURs) and renewal documentation submitted to regulatory agencies.
Provides the patient safety contribution to global regulatory submissions (NDA, BLA, MAA etc) for new products, formulations or indications.