Work as Patient Safety QA Advisor at AstraZeneca

AstraZeneca (AZ) has a bold aspiration to improve the lives of 200 million patients delivering 20 new medicines to patients by 2030. This role is critical in contributing to AZ’s long-term ambition. Global Business Services (GBS) is growing to support critical functions across the whole Enterprise. This role will be specifically focused on defining and delivering GBS opportunities within the R&D areas of the business.

Post : Patient Safety QA Advisor

Job Description
• To partner closely with stakeholders to ensure an end-to-end approach for quality management which includes implementation and monitoring of quality management processesfor patient safety.
• Maintain and enhance the Patient SafetyQuality Management System (QMS), including controlled documents (SOPs/WIs), training curricula, quality metrics, and governance processes.
• Support with the preparation of quality related documentation, including SOPs, WIs and manualsin collaboration with stakeholders and global quality management system.
• Establish and operate the formal change management framework for Patient Safety, including change initiation, impact assessment, risk evaluation, approval workflows, implementation planning, and effectivenessverification inthe system.
• Lead the end-to-end SOP lifecycle —authoring/updates, SME and QA review, approval, version control, periodic review, obsolescence, and archival.
• Analyzequality metrics (KPIs),identifytr ends, and drive continuous improvement initiatives that enhance compliance, efficiency, and inspection readiness.
• Work with the tools to monitor compliance and metrics, and key performance indicators (KPIs) for global PV processes, license partners, and vendors. Ensure feedback and trend analysis to support AstraZeneca continuous improvement. Planand execute risk-based QA activities (internal assessments) covering patient safety activities.Perform internal assessments and quality checkas perpolicy and procedures to ensure audit and inspection readiness.
• Support with audits and regulatory inspections and drive best practices for audit and inspection management in collaboration with the global Quality Assurance teams.
• Lead investigations into quality issues, deviations and non-conformances, determining root-cause and implementing Corrective and Preventative Actions
• Facilitate robust deviation handling, root cause analysis (e.g., 5 Whys, Fishbone), and risk-based CAPA plans; monitor CAPA effectiveness and sustainability.
• Facilitate development of Corrective & Preventive Actions, provide support and guidance on implementation, track progress, collect evidence, and coordinate effectiveness checks.
• Support and monitor risk assessments and monitormitigation actions, SOP revisions, or process changes.
• Proactively support internal training programs related to audit/inspectionreadiness, compliance, and quality performance indicators, ensuring alignment across global PV teams and affiliates.
• Support data governance initiatives to ensure high-quality data for decision-making, assess downstream implications of data activities, and align ongoing initiatives with compliance requirements.
• Ensure compliance with global regulatory requirements, including timely submission of appropriate Regulatory Reports to relevant authorities
• Serve as a subject matter expert during audits and inspections related to QMS process within the hub
• Contribute to the development and optimisation global patient safety processes,systems and tools, including automation solutions
• Stay updated on regional and global pharmacovigilance regulations for those MCs supported by the hub, ensuring that necessary changes are implemented to maintain quality management systems.
• Self-serve training and development of GBS quality and compliance knowledge and skills within the hub.

Candidate Profile
• Bachelor’s degree in life sciences or equivalent
• 2- 3years experience in GxP Quality Assurance in the pharmaceutical, biotechnology, or related industry.
• Hands-on experience with Veeva Vault QMS
• QA Competencies : Change management, root cause analysis, CAPA management, deviation/issue management, audit management and data integrity.
• Strong background in Quality Assurance, with expertise in quality system standards thatimpactmultiple departments
• Knowledge of global safety regulations for both marketed and investigational products
• Exceptional attention to detail and commitment to maintaining high-quality standards
• Ability to work in a fast-paced environment, manage multiple priorities, and meet tight deadlines
• Strong analytical and problem-solving skills
• Excellent communication skills, both written and verbal, with the ability to interact effectively with internal and external stakeholders across different regions
• Ability to work in a team environment / works collaboratively

Desirable skills and qualifications :
• Knowledge of global and regional pharmacovigilance regulations
• Experience in Pharmacovigilance, data management, and adverse event reporting and processing, with proficiency in relevant software tools
• Proficiency in safety databases, ideally Argus, and case management systems
• Proven experience in supporting projects within a highly matrixed, multicultural global setting, demonstrating facilitation, problem-solving, and quality and compliancere solution skills.
• Solid understanding of PV and Clinical Research processes, including their interfaces and contributions to the overall PV system.

Additional Information
Experience : 2- 3 years
Qualification : Bachelor’s degree in life sciences
Location : Bengaluru, Karnataka
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Patient Safety (PS)
Closing Date : 09-Dec-2025