Patient Safety QA Advisor, Patient Safety (PS)

AstraZeneca (AZ) has a bold aspiration to improve the lives of 200 million patients delivering 20 new medicines to patientsby 2030. This role is critical in contributing to AZs long-term ambition. Global Business Services (GBS) is growing to support critical functions across thewholeEnterprise. 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 focusbyestablishingResearch & 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 beestablished ensuring that GBS can offer the broad range of servicesrequiredto support AZ ambitions.

The successful candidate should be an experienced QualityAssuranceprofessionalin patient safetylooking to join a corporate patient safety team as a Patient Safety QualityAssuranceAdvisor. The role will play an integral part inQualityAssuranceTeamsupporting the Patient Safety in the provision of safety and quality services toour Global Marketing Companiesin accordance withtheclients Patient safetyobjectivesandqualityplan. 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 patientsafetyand risk activity acrossAstraZenecas global teams

Ensure the quality compliance and continuous improvement of Patient Safety (PS) role provides independent quality oversight drivesinspectionreadiness and partners with cross-functional teams tomaintainadherence to GVP ICH local regulations and internal quality standardsultimately protectingpatient welfare andsafety.

This role is crucial in ensuring thetimelyandaccuratequalityand compliance from ourBangalorehub contributing to AZs overall global pharmacovigilanceeffortsandultimately supportingpatient safety worldwide.

Accountabilities & Responsibilities:

• To partner closely with stakeholders to ensure an end-to-end approach for qualitymanagement which includes implementation and monitoring of quality management processesfor patient safety.

• Maintain and enhance thePatient SafetyQuality Management System (QMS) including controlled documents (SOPs/WIs) training curricula quality metrics and governance processes.

• Support with the preparationof quality related documentation including SOPs WIs and manualsin collaboration with stakeholders andglobal quality managementsystem.

• Establish andoperatethe formal change management framework for Patient Safety including change initiation impact assessment risk evaluation approval workflows implementation planning andeffectivenessverification inthe system.

• Lead theend-to-end SOP lifecycleauthoring/updates SME and QA review approval version control periodic review obsolescence and archival.

• Analyzequality metrics (KPIs)identifytrends and drive continuous improvement initiatives that enhance compliance efficiency and inspection readiness.

• Work withthetools tomonitorcompliance andmetrics and key performance indicators (KPIs) for global PV processes license partners and vendors. Ensure feedback and trend analysisto support AstraZenecacontinuousimprovement.Planand execute risk-based QA activities (internal assessments) coveringpatient safety activities.Perform internal assessments andqualitycheckas perpolicy and proceduresto ensure audit andinspectionreadiness.

• Supportwithaudits and regulatoryinspections anddrivebest practices for audit and inspection management in collaboration withtheglobalQuality Assurance teams.

• Lead investigations into quality issues deviations and non-conformancesdeterminingroot-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.

• Facilitatedevelopment ofCorrective & Preventive Actions providesupport andguidance on implementation track progress collect evidence and coordinate effectiveness checks.

• Support andmonitorrisk assessmentsandmonitormitigation actions SOP revisions or process changes.

• Proactively supportinternaltraining 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 includingtimelysubmission ofappropriate RegulatoryReports to relevant authorities

• Serve as a subject matter expert during audits and inspections related toQMS processwithin the hub

• Contribute to the development andoptimisationglobal patient safety processessystemsand 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 tomaintainqualitymanagement systems.

• Self-servetraining and development of GBSqualityandcomplianceknowledge and skills within the hub.

• Bachelors degree in life sciencesor equivalent

• 2- 3years experienceinGxPQuality Assurancein the pharmaceutical biotechnology or related industry.

• Hands-onexperiencewithVeeva Vault QMS

• QA Competencies:Change management root cause analysis CAPA management deviation/issue management auditmanagementand data integrity.

• Strong background in Quality Assurance withexpertisein quality system standards thatimpactmultiple departments

• Knowledge of global safety regulations for both marketed and investigational products

• Exceptional attention to detail and commitmenttomaintaininghigh-quality standards

• Ability to work in a fast-paced environmentmanage multiple priorities and meet tightdeadlines

• Strong analytical and problem-solving skills

• Excellent communication skills both writtenand verbal with the ability to interact effectivelywith internal andexternal stakeholders across different regions

• Ability to work in a team environment / works collaboratively
  
  Desirable skills and qualifications:

• Knowledgeof global and regional pharmacovigilance regulations

• Experiencein Pharmacovigilance data management and adverse event reporting and processing withproficiencyin relevant software tools

• Proficiencyin safety databases ideally Argus and case management systems

• Proven experience insupportingprojectswithin a highly matrixed multicultural global settingdemonstratingfacilitation problem-solving andquality and complianceresolution skills.

• Solid understanding of PV and Clinical Research processes including their interfaces and contributions to the overall PV system.