Director, Safety Epidemiology

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

**About the role**

AstraZeneca’s **Safety Epidemiology** team leads the strategy, design, execution, and delivery of post‑authorisation safety studies (PASS) across a broad portfolio of marketed and pipeline medicines. We are also responsible and accountable for generating epidemiological insights to investigate safety signals that helps to inform regulatory decision‑making, benefit-risk assessment, and risk management for AstraZeneca products across multiple therapy areas. We are seeking a **D**irector,**S**afety**E**pidemiology for**G**lobal**M**arkets** to provide pharmacoepidemiology support to local and regional markets, including real world evidence and pharmacovigilance teams in Japan, Korea, China, and India, with potential expansion to additional geographies.

**Key responsibilities**
- ** Lead**PASS** strategy and delivery**: Lead or advise on PASS strategy, study design, protocol development, and execution to meet local regulatory requirements on time and to high quality standards.
- ** Provide scientific leadership**: Offer expert guidance on pharmacoepidemiology and pharmacovigilance methods, including study design optimization, bias control, feasibility, and execution across heterogeneous global, regional or local data sources.
- ** Line management responsibility**:Line management of team members reporting into Safety Epidemiology responsible for the planning and delivery of PASS for local and regional markets.
- ** Collaborate**effectively**with local-market RWE/PV leads**: Work closely with those responsible for generating real-world evidence and pharmacovigilance in local markets to ensure methodological consistency, data quality, and efficient escalation and resolution of study-specific issues.
- ** Operate across time zones and cultures**: Partner with local teams to navigate regulatory nuance while upholding global AZ standards; proactively identify risks, propose scientifically sound solutions, and drive decisions that keep studies on time, on scope, and compliant.
- ** Align local teams to global standards**: Support local teams to adopt and adhere to global standards for delivery, processes, documentation, and ways of working, ensuring consistency, audit readiness, and operational efficiency across markets.
- ** Drive cross-functional alignment**: Partner with Global Patient Safety, Regulatory, Medical, R&D, and internal governance bodies to align strategies, accelerate decisions, and resolve scientific and operational challenges.
- ** Deliver**timely** evidence**: Lead or oversee PASS planning and delivery to support Health Authority queries.
- ** Strengthen benefit-risk assessment**: Advise on benefit-risk characterization and contribute to qualitative and quantitative assessments across the product lifecycle.
- ** Build capability and manage delivery**: Coach colleagues across geographies; oversee CROs and external partners to ensure quality, timeliness, and reproducibility
- ** Shape the future pipeline**: Anticipate upcoming PASS across markets; identify opportunities to streamline approaches and advance scientific methods.

**Impact**

This role directly supports **patient safety**, informs **regulatory decision-making**, and enables continuous access to medicines in complex, rapidly evolving markets. You will influence **portfolio strategy**, elevate **scientific rigor**, and deliver evidence that withstands **Health Authority** scrutiny.

**Growth and opportunity**
- ** Scientific leadership**: Establish best practices for observational methods, causality assessment, and bias mitigation across diverse data ecosystems.
- ** Regional breadth**: Extend impact across multiple markets with varied regulatory landscapes and data environments.
- ** Cross-functional visibility**: Engage with senior leaders and governance bodies on high-stakes issues; gain broad exposure across clinical development, medical, and safety.
- ** People and vendor leadership**: Develop team leadership and vendor management capabilities while mentoring market-based teams.

**Essential qualifications**
- ** Advanced training**: PhD in pharmacoepidemiology/epidemiology; or MD/PharmD with MSc/MPH and substantial real-world evidence experience.
- ** Industry experience**: 8+ years as an epidemiologist in the pharmaceutical industry or equivalent (10+ preferred), with a record of delivering observational studies and PASS/PMCs.
- ** Regulatory engagement**: Experience interacting with Health Authorities on PASS and converting requirements into executable, compliant studies.
- ** Methods**expertise**: Hands-on experience with primary data collection and secondary data analyses; fluency with real-world data sources and patient safety databases.
- ** End-to-end study ownership**: Demonstrated ability to design protocols, lead execution, troubleshoot methodological and operational issues, and deliver to time and quality.
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