Job Description

Title -

Patient Safety

Q

A

Advisor

, Patient Safety

(PS)

Work Location: Manyata Tech Park, Bangalore, India Work Schedule: Three days on-site, two days remote (3/2) Work Hours: 9 am to 6 pm IST or 2 pm to 11 pm IST basis business needs (Transport available as per company policy) Career Level: C - Individual Contributor Years of experience: 3 - 7 years

About role:

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


GBS is enhancing its customer focus by establishing Research & Development (R&D) Services to improve alignment and strengthen our relationships with SET areas. R&D Services is a key element of the GBS Bold Ambition, driving our vision to enable AstraZeneca to change and grow at speed. Between now and 2030 10 new R&D capabilities are to be established, ensuring that GBS can offer the broad range of services required to support AZ ambitions.


The successful candidate should be an experienced Quality Assurance professional in patient safety looking to join a corporate patient safety team as a Patient Safety Quality Assurance Advisor. The role will play an integral part in Quality Assurance Team supporting the Patient Safety in the provision of safety and quality services to our Global Marketing Companies, in accordance with the client's Patient safety objectives and quality plan. This will include supporting Leadership Team(s) to proactively manage quality and promote the highest level of patient safety and ensuring that they are fully informed of all quality, patient safety and risk activity across AstraZeneca's global teams


Ensure the quality, compliance, and continuous improvement of Patient Safety (PS) processes. This role provides independent quality oversight, drives inspection readiness, and partners with cross-functional teams to maintain adherence to GVP, ICH, local regulations, and internal quality standards--ultimately protecting patient welfare and safety.


This role is crucial in ensuring the timely and accurate quality and compliance from our Bangalore hub, contributing to AZ's overall global pharmacovigilance efforts and ultimately supporting patient safety worldwide.

Accountabilities & Responsibilities:

To partner closely with stakeholders to ensure an end-to-end approach for quality management which includes implementation and monitoring of quality management processes for patient safety. Maintain and enhance the Patient Safety Quality 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 manuals in 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 effectiveness verification in the system. Lead the end-to-end SOP lifecycle --authoring/updates, SME and QA review, approval, version control, periodic review, obsolescence, and archival. Analyze quality metrics (KPIs), identify trends, 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. Plan and execute risk-based QA activities (internal assessments) covering patient safety activities. Perform internal assessments and quality check as per policy 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 monitor mitigation actions, SOP revisions, or process changes. Proactively support internal training programs related to audit/inspection readiness, 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.

Typical People Management Responsibility (direct/indirect reports)

Approx. number of people managed in total (all levels) - No Matrix Manager - (projects/dotted line) - No Manager of a team - No Manager of a Manager - No

Essential skills and qualifications:

Bachelor's degree in life sciences or equivalent 2- 3 years 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 that impact multiple 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 compliance resolution skills. Solid understanding of PV and Clinical Research processes, including their interfaces and contributions to the overall PV system.

Key Relationships to Reach Solutions

Internal (to company or team)

Bangalore Hub Facilities Team, R&D Functional Teams - including but not limited to Patient Safety, Site management and Monitoring (SM&M), Clinical Operations, Regulatory Operations, Global Business Services, R&D Transformation management teams, Global AZ Procurement, Global AZ Legal & Regulatory, Global AZ Compliance, Global Medical Affairs, Global Digital/Regional Leads, Legal, Global R&D IT, Marketing teams

External (to company)

External Service Providers, License Partners, Health Authorities, Professional societies or organizations, OSPs
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.



AstraZeneca offers an environment where diverse cultures and perspectives come together to create a sense of belonging. Here you'll find opportunities to learn and grow alongside a team committed to transforming processes through simplification and automation. Our innovative approach ensures that data is at the heart of everything we do. As part of our journey of growth and evolution, you'll contribute to making AstraZeneca more agile and efficient while impacting society positively.



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