Medical Director, Patient Safety Physician

hace 5 meses

Barcelona, España AstraZeneca A tiempo completo

Join us at AstraZeneca in the Vaccines and Immune Therapies division as a Medical Director, 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.

**Main responsibilities**:

- Working with the Safety Team, be 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. 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, MedImmune 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/MedImmune Safety Review 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.

**Essential Skills/Experience**:

- 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

**Desirable Skills/Experience**:

- 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

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn't mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

At AstraZeneca, we are changemakers on the world stage. We are helping to transform healthcare and build pandemic preparedness to protect against future health crises. We are team players, investing in ground-breaking collaborations, local partnerships, and commercial initiatives. In everything we do, people come first. We are challenging the norm, going above and

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