Overview
Director, Safety Epidemiology – Global Markets at AstraZeneca. Location: Barcelona - Spain (3 days in office and 2 days from home).
Responsibilities
* Lead PASS strategy and delivery: 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: guide pharmacoepidemiology and pharmacovigilance methods across global, regional, or local data sources.
* Line management: supervise Safety Epidemiology team members responsible for planning and delivering PASS for local and regional markets.
* Collaborate with local-market RWE/PV leads: ensure methodological consistency, data quality, and efficient issue resolution.
* Operate across time zones and cultures: work with local teams to navigate regulatory nuance while upholding global AstraZeneca standards; identify risks and drive on-time, in-scope, compliant studies.
* Align with global standards: help local teams adopt global delivery, documentation, and working practices; ensure audit readiness and operational efficiency.
* Drive cross-functional alignment: partner with Global Patient Safety, Regulatory, Medical, R&D, and governance bodies to align strategies 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 and timeliness.
* Shape the future pipeline: anticipate upcoming PASS across markets and identify opportunities to streamline approaches and advance 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.
* Cross-functional visibility: engage with senior leaders and governance bodies on high-stakes issues; gain 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: ability to design protocols, lead execution, troubleshoot issues, and deliver on time and to high quality.
* Cross-functional effectiveness: capable of representing epidemiology on multidisciplinary teams and influencing decisions across geographies.
* Communication: clear, precise communicator able to synthesize complex science for diverse stakeholders.
* Leadership: line management or matrix leadership experience; ability to coach teams and manage CROs.
Desirable Qualifications
* Global Markets exposure: experience conducting PASS in US, Europe, Japan, Korea, China, India, or other markets.
* Regulatory depth: knowledge of international drug safety reporting requirements, PASS methodologies, and Health Authority expectations.
* Drug development fluency: understanding lifecycle evidence needs, trials, and post-marketing pharmacovigilance operations.
* Vendor oversight: experience managing external research partners to deliver high-quality, audit-ready outputs.
* AI familiarity: ability to use AI/ML tools appropriately to enhance workflows and deliverables, with sound governance and validation.
Success Measures
* PASS delivered on schedule, within scope, and compliant with market requirements.
* Defensible study designs and outputs that withstand 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.
Date Posted: 10-sept-2025
Closing Date: 29-sept-2025
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with diverse perspectives. We comply with all applicable laws and regulations on non-discrimination, work authorization, and employment eligibility verification.
Seniority level
* Director
Employment type
* Full-time
Job function
* Management and Manufacturing
Industries
* Pharmaceutical Manufacturing
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