Associate Director, Patient Safety Scientist

Location: Barcelona - Spain (3 days working from the office and 2 days working from home)

Introduction:

The   Associate Director, Patient Safety Scientist   role works 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.    He/she   has the ability to   provide authoring and PV input to safety documents and regulatory reports.   Associate Director, Patient Safety Scientist   also has the ability to   lead meetings and present safety data and analyses.

Main Responsibilities:

- Leads and/or conducts proactive pharmacovigilance and risk management planning for designated products, including preparation of safety aspects of   G lobal 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.

Requirements – Education and Experience

- 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

Date Posted
08-sept-2026

Closing Date
21-sept-2026

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.