Qa Advisor - Global Business Services

3+ years

Not Disclosed

Remote

10 April 23, 2025

Job Description

Job Type: Full Time Education: BA/BS Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: QA Advisor - Global Business Services

Location: [Insert Location Here]

Career Level: C

Introduction to Role: AstraZeneca (AZ) has a bold aspiration to improve the lives of 200 million patients by delivering 20 new medicines 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 specifically focus 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 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 will be established, ensuring that GBS can offer the broad range of services required to support AZ’s ambitions.

The successful candidate should be an experienced Patient Safety or Quality professional looking to join a corporate patient safety team as a Patient Safety Quality Advisor. The role will play an integral part in supporting the Patient Safety and Quality Team in providing 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 Teams to proactively manage quality, promote the highest level of patient safety, and ensure they are fully informed of all quality, patient safety, and risk activity across AstraZeneca’s global teams. This role is crucial in ensuring timely and accurate quality and compliance from our Bangalore hub, contributing to AZ’s overall global pharmacovigilance efforts and supporting patient safety worldwide.

Accountabilities:

Support the efficient processing and reporting of adverse event cases within regulatory timelines:

Implement and maintain standardized operating procedures (SOPs) for case intake and processing, ensuring consistency with global pharmacovigilance practices.
Support the preparation, review, and approval of quality-related documentation, including SOPs, batch records, and validation protocols, ensuring accuracy and compliance.
Work with tools to monitor compliance, quality metrics, and key performance indicators (KPIs) for global PV processes, license partners, and vendors. Ensure feedback and trend analysis to support AstraZeneca continuous improvement.

Support internal assessments, external audits, and regulatory inspections:

Drive best practices for audit and inspection management in collaboration with the client’s Quality Assurance teams.
Lead investigations into quality issues, deviations, and non-conformances, determining root causes and implementing Corrective and Preventive Actions.
Respond to Corrective & Preventive Actions and deviation processes, providing support and guidance on development and implementation, tracking progress, collecting evidence, and coordinating effectiveness checks.

Proactively support internal training programs related to audit/inspection readiness, compliance, and quality performance indicators:

Ensure 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:

Ensure timely submission of appropriate Regulatory Reports to relevant authorities.
Serve as a subject matter expert during audits and inspections related to case intake processes within the hub.
Contribute to the development and optimization of 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 compliance.

Self-serve training and development of GBS quality and compliance knowledge:

Develop skills within the hub.

Essential Skills/Experience:

BA or BS degree or equivalent.
Experience in the pharmaceutical, biotechnology, or related industry.
Experience in Pharmacovigilance, data management, and adverse event reporting and processing, with proficiency in relevant software tools.
Strong background in Pharmacovigilance, Regulatory Affairs, or Safety 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 in case processing and reporting.
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 and collaborate effectively.

Desirable Skills/Experience:

Knowledge of global and regional pharmacovigilance regulations.
Track record in managing and optimizing Patient Safety processes.
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.

Work Model:

Minimum of three days per week in-office, with flexibility to accommodate individual needs.

About AstraZeneca: We couple technology with an inclusive mindset to cross international boundaries and develop a leading ecosystem. A diverse group, we work in cross-functional teams at scale, bringing together the best minds from across the globe to uncover new solutions. Here we think holistically about how to apply technology, building partnerships inside and out. We drive simplicity and efficiencies to make a real difference.

Ready to make an impact? Apply now!

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Qa Advisor - Global Business Services

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