Global Markets Associate Director, Safety Epidemiology

About this role

Responsibilities

• Lead PASS 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 guidance on pharmacoepidemiology and pharmacovigilance methods, including study design optimization, bias control, feasibility, and execution across heterogeneous global, regional or local data sources.
• Collaborate 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 characterisation and contribute to qualitative and quantitative assessments across the product lifecycle.
• Build capability and lead 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; find opportunities to streamline approaches and advance scientific methods.

Requirements

• Ph.D. or equivalent in pharmacoepidemiology or epidemiology. Alternatively, an MD/PharmD or equivalent with MSc or MPH with experience in a health care environment focusing on RWE studies in the context of regulatory and drug safety
• Strong interpersonal and communication skills to work collaboratively across multiple time zones, geographies, and business functions
• Experience in pharmacoepidemiology and pharmacovigilance study design and execution
• Experience planning and completing PASS on behalf of Global Markets
• Knowledge and experience with drug safety reporting and regulatory compliance and experience with international requirements and pharmacovigilance regulations
• Hands-on experience in applying secondary data and primary data collection studies and knowledge of patient safety databases for use in generating RWE.
• Ability to apply advanced epidemiological theory and techniques in the context of regulatory and drug safety
• Able to provide critical appraisal to study designs and published studies
• Understanding of drug safety and medical terminology and ability to summarise medical information drug safety experience in a clinical or post-marketing environment.
• Experience with working internal & external authorities, collaborative groups and contract research organisations (CROs)
• Desirable qualifications
• Industry experience as an epidemiologist in the pharmaceutical industry or equivalent, with a record of delivering observational studies and PASS/PMCs.
• Experience with conducting PASS in US, Europe, Japan, Korea, China, India, or other local or regional markets.
• Basic understanding of lifecycle evidence needs, trials, and post-marketing pharmacovigilance operations.
• Experience leading 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 judgement regarding limitations, validation, and governance.
• In Office Requirement:
• When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
• Competitive salary and benefits package on offer!
• The successful candidate will have access to a flexible employee benefits fund, including holiday purchase and flexible time off, pension contributions, Share Save Plans, A performance recognition scheme and a competitive, generous remuneration package.
• Date Posted
• 29-Apr-2026
• Closing Date
• 05-May-2026
• Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.

About AstraZeneca BE

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies. At AstraZeneca, we are pioneering new frontiers by identifying and treating patients earlier, working towards the aim of eliminating cancer as a cause of death. Come and join our AZ team where you will play a pivotal role in this exciting period of development! The Associate Director will be responsible for leading global market PARCS strategy, supporting and/or developing PARCS deliverables across various products in the AZ portfolio. They will also support and coordinate the collaboration with various global functions within AZ such as Global Patient Safety, Regulatory, Medical, R&D and AZ internal governance bodies such as ERT/MARC(O), to ensure strategic and operational alignment and to develop strategic plans for using epidemiological tools and methods. Importantly, they will ensure studies are designed and implemented in accordance with the regulatory requirements and other internal AZ SOPs to either fulfil requests from local health authorities or in anticipation of such requests. They will be involved in understanding and anticipating the pipeline of future PARCS across the Global Markets. The individual will be the primary scientific authority providing scientific guidance and direction for pharmacoepidemiology. The role includes engagement with senior leaders, and collaboration with senior colleagues and peers to ensure optimal management of relevant studies. They will also be responsible for other license to operate activities for the Global Markets, such as literature reviews and rapid analytics of large electronic healthcare data (EHR), to support pharmacovigilance and responses to health authority queries (HAQs).