Associate Director, Patient Safety Scientist

hace 3 semanas

Barcelona, España AstraZeneca A tiempo completo

Are you ready to make a big impact? Join our dedicated Patient Safety Vaccines & Immune Therapies team that's growing fast and building a strong track record of success. Our pioneering approach is identifying and treating patients earlier, focusing on early stage cancer trials and listening and evolving based on their needs. As an Associate Director, Patient Safety Scientist, you will work collaboratively with the Global Safety Physician (GSP) and (Senior/Principal) PV Scientist with the review of safety data and related documents for potential safety issues. You will have the ability to provide authoring and PV input to safety documents and regulatory reports.

**Accountabilities**:
In this role, you will lead and/or conduct proactive pharmacovigilance and risk management planning for designated products, including preparation of safety aspects of Global Risk Management Plans. You will represent PS on cross-functional project teams for developmental compounds and/or marketed products. You will have the ability to present safety information at external meetings and perform duties as a Safety Strategy and Management Team (SSaMT) leader for smaller or less complex projects.

**Main Responsibilities**:

- Leads and/or conducts proactive pharmacovigilance and risk management planning for designated products, including preparation of safety aspects of Global Risk Management Plans, in partnership with the GSP and others as appropriate.
- Represents PS on cross-functional project teams for developmental compounds and/or marketed products.
- Has the ability to present safety information at meetings.
- Has the ability to perform duties as a Safety Strategy and Management Team (SSaMT) leader for smaller or less complex projects.
- Presents issues to Safety Information Review Committee (SIRC) and has the capacity to take the lead role in data evaluation and discussion of the results with the SIRC Chair, GSP and other key stakeholders.
- Produces accurate and fit for purpose evaluation documents with clear conclusions in response to internal or regulatory authority requests for safety data.
- Collaborates with GSP and Clinical representatives and authors the Reference Safety Information (RSI) for assigned development products; coordinates meetings and tracks timelines to ensure completion.
- Proactively evaluates the clinical implications of safety data from pre-clinical studies, clinical studies, literature and other information sources to establish the safety profile of drugs and manage the risk to patients.
- Authors/provides strategic input or oversight for periodic regulatory documents (PBRERs, PSURs, DSURs) according to the agreed process and timelines.
- Authors/provides strategic input to regulatory submissions for new products, formulations or indications (NDA/BLA, MAA), in partnership with the GSP and other functional experts.
- Contributes to the PS component of contracts/agreements with third parties to ensure quality and integrity of agreement.
- Trains junior members of the team in PS tools and systems.

**Essential Skills/Experience**:

- A life sciences/pharmacy/nursing degree
- Demonstrated Patient Safety and/or Clinical/ Drug Development experience
- Intermediate knowledge of PV regulations
- Fluent in written and verbal English

**Desirable Skills/Experience**:

- MSc/PhD in scientific discipline
- Basic understanding of epidemiology 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.

Why AstraZeneca?
Join the team dedicated to Oncology, with an ambition to eliminate cancer as a cause of death. It's our big vision that unites and inspires us. With multiple indications and high-quality molecules at all stages of our innovative pipeline, we keep pushing forward. Fusing cutting-edge science with the latest technology to achieve breakthroughs. Backed by investment, we are aiming to deliver 6 new molecular entities by 2025.

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