Director-Level Patient Safety Scientist & Strategy Lead

AstraZeneca; Barcelona; Híbrido; EUR 90.000 - 130.000; Jornada completa

Descripción de la vacante

AstraZeneca is seeking an Associate Director, Patient Safety Scientist to collaborate with GSP and PV teams in reviewing safety data and preparing safety inputs for regulatory reports. The role includes leading cross-functional safety discussions and authoring safety documents to support product development and lifecycle management.

You will lead meetings, present safety data, and oversee RSIs and regulatory submissions, ensuring timely delivery of safety evaluations while training junior staff

Formación

• A life sciences/pharmacy/nursing degree, and demonstrated Patient Safety and/or Clinical/ Drug Development experience.
• Intermediate knowledge of PV regulations
• Fluent in written and verbal English
• MD, MSc/PhD in scientific discipline, preferred
• Basic understanding of epidemiology data, preferred

Responsabilidades

• 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 external 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.

Conocimientos

Patient Safety

Pharmacovigilance

GSP

PV Scientist

Regulatory submissions

Data review

Safety documents

Educación

Life sciences/pharmacy/nursing degree

MD/MSc/PhD preferred

Descripción del empleo

AstraZeneca is seeking an Associate Director, Patient Safety Scientist to collaborate with GSP and PV teams in reviewing safety data and preparing safety inputs for regulatory reports. The role includes leading cross-functional safety discussions and authoring safety documents to support product development and lifecycle management.

You will lead meetings, present safety data, and oversee RSIs and regulatory submissions, ensuring timely delivery of safety evaluations while training junior staff