Patient Safety QA Advisor – Patient Safety (PS)
Location: Manyata Tech Park, Bangalore, India
Work Mode: Hybrid (3 days onsite, 2 days remote)
Work Hours: 9 AM–6 PM IST or 2 PM–11 PM IST
Experience Required: 3–7 Years
Career Level: Individual Contributor
Job Type: Full-Time
Job ID: R-240905
Apply Before: 10 December 2025
Position Overview
AstraZeneca is seeking an experienced Patient Safety Quality Assurance Advisor to support global patient safety operations from its Bangalore hub. This role is essential to maintaining a robust Patient Safety Quality Management System (QMS), ensuring adherence to global pharmacovigilance regulations, and strengthening inspection readiness across AstraZeneca’s global safety network.
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Role Purpose
The Patient Safety QA Advisor will provide independent quality oversight, ensure compliance with GVP and ICH standards, manage controlled documentation, and drive continuous improvement within Patient Safety (PS) functions. The role strengthens AstraZeneca’s global pharmacovigilance framework by ensuring that quality, compliance, and risk mitigation practices are rigorously implemented across the Bangalore hub.
Key Responsibilities
Quality Management and Compliance
Maintain and enhance the Patient Safety Quality Management System (QMS), including SOPs, WIs, training curricula, metrics, and governance.
Partner with global and regional stakeholders to ensure cohesive end-to-end quality management across patient safety operations.
Lead the full SOP lifecycle including authoring, updates, reviews, approvals, version control, periodic review, and archival.
Quality Documentation and Change Control
Support creation, revision, and maintenance of controlled documents aligned with global standards.
Operate and manage the formal change management framework for Patient Safety including impact analysis, risk evaluation, implementation tracking, and effectiveness checks.
Quality Metrics and Continuous Improvement
Analyze quality KPIs and metrics to identify trends, deviations, and improvement areas.
Drive continuous improvement initiatives to enhance operational efficiency and inspection readiness.
Monitor compliance for PV processes, vendors, and licensing partners.
Audit and Inspection Readiness
Prepare teams for internal and external audits in collaboration with global QA teams.
Conduct internal quality assessments and evaluations as per SOPs and regulatory expectations.
Serve as Subject Matter Expert (SME) for QMS-related processes during audits and regulatory inspections.
Deviation, CAPA, and Risk Management
Lead investigations into quality deviations and non-conformances, applying structured root cause analysis tools such as 5 Whys and Fishbone.
Develop, implement, and monitor CAPA plans and verify their long-term effectiveness.
Support ongoing risk assessments and ensure mitigation strategies are executed and tracked appropriately.
Training, Data Governance, and Cross-Functional Support
Support internal training programs related to quality management, compliance, and inspection readiness.
Contribute to data governance initiatives ensuring high-quality data for decision-making.
Support optimization of global patient safety processes, systems, and digital tools, including automation initiatives.
Experience and Qualifications
Essential
Bachelor’s degree in Life Sciences or equivalent.
3–7 years of experience in GxP Quality Assurance within the pharmaceutical or biotechnology industry.
Hands-on experience with Veeva Vault QMS.
Strong competencies in change management, deviation management, CAPA, audits, data integrity, and QMS operations.
Knowledge of global safety regulations for both marketed and investigational products.
Strong analytical, communication, and problem-solving skills.
Ability to manage multiple priorities in a fast-paced, global environment.
Desirable
Experience in Pharmacovigilance operations including adverse event reporting, case processing, and safety database usage (preferably Argus).
Prior involvement in global or matrixed projects across multicultural environments.
Knowledge of clinical research processes and PV system interfaces.
Key Internal and External Stakeholders
Internal
Bangalore Hub Facilities
Global Patient Safety
Clinical Operations
Regulatory Operations
Global Business Services
R&D Transformation Teams
Legal, IT, Medical Affairs, Procurement, and Digital Leads
External
Health Authorities
Licensing Partners
External Service Providers
Professional Organizations
Work Environment
AstraZeneca promotes a dynamic hybrid work model combining in-person collaboration and individual flexibility. Teams are encouraged to connect onsite at least three days per week to support rapid decision-making, knowledge sharing, and innovation.
Why Join AstraZeneca
AstraZeneca offers an inclusive environment that values diversity, fosters professional growth, and encourages innovative thinking. Employees have opportunities to contribute to global patient safety initiatives and participate in ongoing transformation and digital optimization efforts across the organization.
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