Director, Safety Epidemiology – Global Markets

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 Director, Safety Epidemiology for Global Markets 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 additionalgeographies.

Key responsibilities

• Lead PASS strategy and delivery: Lead or advise onPASS 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, regionalorlocaldata 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 andPASS/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.

• Cross-functional effectiveness: Proven ability to represent epidemiology on multidisciplinary teams and influence decisions across functions and geographies.

• Communication: Clear, precise communicator able to synthesize complex science for diverse stakeholders.

• Leadership: Line management and/or matrix leadership experience; capability to coach teams and manage CROs.

Desirable qualifications

• Global Markets exposure: Experience with conducting PASS in US, Europe, Japan, Korea, China, India, or other local or regional markets.

• Regulatory depth: Some knowledge of international drug safety reporting requirements, PASS methodologies, and Health Authority expectations.

• Drug development fluency: Basic understanding of lifecycle evidence needs, trials, and post-marketing pharmacovigilance operations.

• Vendor oversight: Experience managing external research partners to deliver high-quality, audit-ready outputs.

• Familiarity with AI enablement: Proficient in the appropriate, compliant use of AI/ML tools to enhance day-to-day workflows and project deliverables, with sound judgment regarding limitations, validation, and governance.

Success measures

• PASS delivered on schedule, to scope, and fully compliant with market requirements.

• Defensible study designs and outputs that withstand internal and Health Authority scrutiny.

• Strong cross-functional partnerships and enhanced epidemiology capability across Global Markets.

• Prioritized pipeline of future PASS with strategies to accelerate delivery and elevate scientific rigor.