Shanghai, Shanghai, China · On-site
Typical Accountabilities - Manage the triage, evaluation, and follow-up of safety documents and clinical or post marketed adverse event information, ensuring accuracy, validity, and compliance with regulations. - Apply s…
Skills: Patient Safety, Pharmacovigilance, Regulatory Reporting, Team Leadership, Clinical Research
Dublin, Leinster, Ireland · On-site
Country Director, Ireland Dublin, Ireland AstraZeneca is a global, science-led biopharmaceutical company driven by one purpose: to push the boundaries of science to deliver life-changing medicines. We are now seeking an …
Skills: Strategic Planning, P&L Management, Leadership, Market Access, Stakeholder Engagement
Lisbon, Portugal · Hybrid
Are you ready to define how AI safely scales across a global enterprise so patients receive medicines reliably and at speed? In this role, you will build the guardrails and operating model that enable responsible AI in c…
Skills: AI Governance, Risk Management, Compliance, Operating Model Design, Portfolio Management
China · On-site
工作目的 在所负责的业务区域内, 利用医学专业知识和科学领导力，以病患为中心，建立稳固的合作共赢关系，实现产品的学术交流有效性，推动业务可持续的增长。 主要职责 拟订医药产品推广计划和方案； 向医务人员传递医药产品相关信息； 协助医务人员合理使用本企业医药产品； 收集、反馈药品临床使用情况及医院需求信息。 医学代表可通过下列形式开展学术推广等活动： 在医疗机构当面与医务人员和药事人员沟通；举办学术会议、讲座；提供学术资料；通过互联网或者…
Skills: Medical Knowledge, Scientific Leadership, Academic Promotion, Interpersonal Communication, Problem Solving
Cuautitlán, State of Mexico, Mexico · On-site
Location: CDMX Availability to travel: Pachuca, Yucatán, Cuernavaca AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of pres…
Skills: Medical liaison, Oncology, Relationship management, Scientific communication, Project management
Argentina · On-site
Objetivo del Puesto:Desarrollar y liderar la estrategia de marketing para los productos asignados dentro de Cono Sur. Con especial foco en la preparación y ejecución de lanzamientos de nuevas moléculas e indicaciones. As…
Skills: Marketing strategy, Product launch, Rare diseases, Market analysis, Competitive differentiation
Waltham, Massachusetts, United States · Hybrid
$139k–$209k/yr
Senior Business Analyst – Biologics Discovery Platform Introduction to role: Are you ready to accelerate the discovery of life-changing medicines? At AstraZeneca, we unite modern science with data-driven, platform-enable…
Skills: Business analysis, Biologics discovery, Molecular biology, Antibody discovery, Requirements gathering
Beijing, Beijing, China · On-site
Role Summary Lead data governance for AstraZeneca’s China R&D office, aligning local policies and controls to enterprise standards. Set policy, assess and mitigate data/AI risk, advise projects, and ensure compliance wit…
Skills: Data Governance, AI Governance, Regulatory Compliance, Cross-Border Data Transfer, Risk Management
Cotia, São Paulo, Brazil · Hybrid
Você quer transformar ciência de ponta em acesso seguro e rápido para pacientes no Brasil? Pronto para conduzir estratégias regulatórias que destravam lançamentos e garantem a continuidade do portfólio? Aqui, sua voz téc…
Skills: Regulatory Affairs, Anvisa Compliance, Pharmaceutical Dossier Preparation, Regulatory Strategy, Good Manufacturing Practices
Dublin, Leinster, Ireland · On-site
This is what you will do: Specialist, Safety, Health & Environment will provide environmental, health, and safety support for all operations at the Alexion Dublin Manufacturing Facility. You will be responsible for: SHE …
Skills: Safety, Health & Environment (SHE), Regulatory Compliance, Incident Management, Root Cause Analysis, Hazard Assessment
Boston, Massachusetts, United States · Hybrid
$70k–$105k/yr
Act as a strategic enabler to senior leaders across AstraZeneca's Biopharmaceuticals Business Unit, operating within a shared, function-agnostic support model. This role moves beyond traditional administration toward pri…
Skills: Executive support, Strategic prioritization, Stakeholder management, Project coordination, Microsoft 365
Hamburg, Germany · On-site
Innovativ, dynamisch und nachhaltig: Als eines der weltweit führenden Unternehmen der forschenden Arzneimittelindustrie bieten wir bei AstraZeneca die besten Möglichkeiten für Ihre persönliche und berufliche Entwicklung.…
Skills: Oncology, Breast cancer, Account management, Stakeholder management, Market analysis
Dublin, Leinster, Ireland · On-site
This is what you will do: As Director, IT Business Partner – Quality, you will serve as a strategic IT leader interfacing with the Quality organization in the Rare Disease Unit (RDU). You will drive the development and e…
Skills: IT Strategy, Quality Management Systems, Digital Transformation, GxP Compliance, Data Integrity
Barcelona, Catalonia, Spain · Hybrid
Job Title: Regulatory Affairs Manager Introduction to role: This role is based in Barcelona, with an on-site commitment of three days a week. Fluency in English is required. Are you ready to steer complex, high-impact re…
Skills: Regulatory Strategy, Submission Planning, Health Authority Engagement, Regulatory Compliance, Regulatory Intelligence
Barcelona, Catalonia, Spain · Hybrid
Job Title: Senior Clinical Data Manager II Introduction to role: This role is based in Barcelona, with an on-site commitment of three days a week. Fluency in English is required. Are you ready to lead study-level data st…
Skills: Clinical Data Management, Vendor Oversight, GCDMP, Electronic Data Capture (EDC), Query Management
China · On-site
工作目的 在所负责的业务区域内, 利用医学专业知识和科学领导力，以病患为中心，建立稳固的合作共赢关系，实现产品的学术交流有效性，推动业务可持续的增长。 主要职责 拟订医药产品推广计划和方案； 向医务人员传递医药产品相关信息； 协助医务人员合理使用本企业医药产品； 收集、反馈药品临床使用情况及医院需求信息。 医学代表可通过下列形式开展学术推广等活动： 在医疗机构当面与医务人员和药事人员沟通；举办学术会议、讲座；提供学术资料；通过互联网或者…
Skills: Medical Knowledge, Scientific Leadership, Academic Promotion, Interpersonal Communication, Problem Solving
China · On-site
工作目的 在所负责的业务区域内, 利用医学专业知识和科学领导力，以病患为中心，建立稳固的合作共赢关系，实现产品的学术交流有效性，推动业务可持续的增长。 主要职责 拟订医药产品推广计划和方案； 向医务人员传递医药产品相关信息； 协助医务人员合理使用本企业医药产品； 收集、反馈药品临床使用情况及医院需求信息。 医学代表可通过下列形式开展学术推广等活动： 在医疗机构当面与医务人员和药事人员沟通；举办学术会议、讲座；提供学术资料；通过互联网或者…
Skills: ,Medical Knowledge, Scientific Leadership, Academic Promotion, Interpersonal Communication, Problem Solving
Gaithersburg, Maryland, United States · Hybrid
$186k–$279k/yr
Director, AI Content Strategy & Capabilities Are you ready to turn AI into measurable content impact across global commercial teams? In this director-level role, you will connect real business needs with practical AI cap…
Skills: AI Content Strategy, Content Supply Chain Management, Stakeholder Management, AI Solution Development, Content Compliance
United Kingdom · On-site
Clinical Advisor - Cell Therapy Loation: Filedbased , UK Introduction to role: Are you ready to turn cutting-edge cell therapy science into real-world trial performance and meaningful patient impact? In this role, you wi…
Skills: Cell Therapy, Clinical Research, GCP, Stakeholder Management, Protocol Education
Hamburg, Germany · On-site
Innovativ, dynamisch und nachhaltig: Als eines der weltweit führenden Unternehmen der forschenden Arzneimittelindustrie bieten wir bei AstraZeneca die besten Möglichkeiten für Ihre persönliche und berufliche Entwicklung.…
Skills: Account Management, Medical Sales, Market Analysis, Stakeholder Management, Communication Skills
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Manage the triage and evaluation of safety documents and adverse event information to ensure regulatory compliance. Lead and mentor the local patient safety team while collaborating with external regulatory authorities and internal cross-functional teams.
Requires a bachelor's degree in science or healthcare with extensive experience in pharmaceutical patient safety and thorough knowledge of FDA and ICH regulations. Demonstrated leadership skills and the ability to manage resources and priorities in a global environment are essential.
Typical Accountabilities
- Manage the triage, evaluation, and follow-up of safety documents and clinical or post marketed adverse event information, ensuring accuracy, validity, and compliance with regulations.
- Apply scientific and technical expertise in patient safety, supporting assessments, research, and regulatory reporting, while serving as a knowledge resource and offering statistical consultancy within the department and across teams.
- Lead and mentor the local patient safety team by monitoring performance, hold direct line management responsibility, set individual objectives, conduct performance management, support career development, encourage professional development, assist with succession planning, and delegate of responsibilities and projects.
- Collaborate with external organizations, regulatory authorities, and cross-functional internal teams to ensure the alignment, quality, and integrity of patient safety processes, data, and submissions.
- Develop and support functional, regional, or country-level patient safety strategies, driving continuous improvement initiatives to meet organizational objectives, enhance efficiency, and optimize project outcomes.
- Represent AstraZeneca’s Patient Safety function externally, networks with industry peers, and promote a culture of courageous leadership, collaboration, and continuous improvement.
Qualifications and Skills
Essential: Bachelor’s degree in science or healthcare-related field (or equivalent patient safety experience); advanced degree preferred; extensive experience in patient safety within pharmaceutical, hospital, clinical research, or healthcare settings (including roles as a Specialist within AstraZeneca Patient Safety); thorough knowledge of patient safety processes, local regulations, and international standards (e.g., FDA and ICH regulations for patient safety and adverse event reporting); broad competence with medical, therapeutic, and technical terminology; demonstrated leadership with the ability to motivate, empower, and guide teams to achieve objectives, including cross-functional team leadership; proven ability to manage priorities, resources, performance targets, and project initiatives in global and regional environments; excellent written and verbal communication skills, along with negotiation, collaboration, and interpersonal leadership abilities; proactive in identifying patient safety issues, implementing solutions, and fostering partnerships with internal and external stakeholders; experience in budgetary and resource management planning; willingness to travel domestically and internationally.
Desirable: Advanced degree in scientific discipline; expert-level recognition across industry; extensive insights into emerging technical regulations; plans, coordinates, and achieves team goals effectively; operational expertise in risk planning and contingencies; exemplifies AstraZeneca leadership values and behaviors; broad understanding of disease complexities with awareness of cutting-edge research and thought leadership; leverages technology and systems to optimize tasks within e-enabled frameworks; exhibits strategic influence and maintains organizational positivity; skilled in conceptual, analytical, and strategic problem-solving; adept in conflict resolution with team-oriented approaches; comprehensive knowledge of AstraZeneca protocols and global guidelines; proven project management, time management, and organizational skills; delivers training and mentoring for adverse event reporting and professional development; proactively seeks continuous learning opportunities in pharmaceutical sciences.
Key Relationship to Reach Solutions
Internal: Senior Management within Patient Safety; Compliance Team; Members of Development function.
External: External service providers and regulatory bodies.
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.
We're transforming the future of healthcare by unlocking the power of what science can do for people, society and the planet. For more information, visit www.astrazeneca.com. Community Guidelines: bit.ly/2MgAcio
Offices: 1 Francis Crick Avenue, Cambridge Biomedical Campus, Cambridge, Cambridgeshire CB2 0AA, GB · Astraallen, Sodertalje, Stockholm County 152 57, SE
We're transforming the future of healthcare by unlocking the power of what science can do for people, society and the planet. For more information, visit www.astrazeneca.com. Community Guidelines: bit.ly/2MgAcio
Offices: 1 Francis Crick Avenue, Cambridge Biomedical Campus, Cambridge, Cambridgeshire CB2 0AA, GB · Astraallen, Sodertalje, Stockholm County 152 57, SE
