Gbs Patient Safety Senior Director

10-15 years

Not Disclosed

Remote

10 April 23, 2025

Job Description

Job Type: Full Time Education: MBA/PhD 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: GBS Patient Safety Senior Director

Location: [Insert Location Here]

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. The Global Business Services (GBS) division is growing to support critical functions across the enterprise. This role will focus specifically 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. Between now and 2030, 10 new R&D capabilities are to be established to ensure GBS can support AZ's ambitions.

The Patient Safety Senior Director leads teams delivering Patient Safety-specific services to R&D Global Patient Safety Local Markets within the GBS organisation. The role ensures service alignment with customer strategies, proactively identifies capability gaps, and fosters collaboration between direct reports and partnering teams. This strategic leadership role requires deep knowledge of pharmacovigilance, global regulatory requirements, and strong organisational and communication skills to drive improvements and collaboration.

Accountabilities:

Strategic Leadership & Relationship Management:

Manage the relationship with Global Patient Safety (GPS) and work with GPS to oversee Patient Safety strategic initiatives and continuous improvements.
Resolve issues escalated from GBS Patient Safety operations and track KPI trends, SLAs, and satisfaction.
Lead and manage a team of Patient Safety Hub Directors, providing mentorship, guidance, and performance management.

Process & System Optimization:

Develop and implement global strategies to optimise Patient Safety processes, ensuring efficiency, quality, and compliance across geographic hubs.
Establish and maintain SOPs for case intake and processing, ensuring regulatory compliance and consistency.
Oversee the implementation and optimization of global Patient Safety processes, systems, and tools, including automation solutions.

Collaboration & Compliance:

Collaborate with HR, Global R&D IT, and Audit to ensure seamless integration of Patient Safety activities.
Track global Patient Safety metrics and performance indicators, initiating continuous improvement initiatives as required.
Serve as the primary point of contact for regulatory authorities during inspections and audits related to global case intake processes.

Vendor & Partner Management:

Manage relationships with external vendors, ensuring compliance with contractual obligations and high-quality standards.
Stay informed about evolving global pharmacovigilance regulations and implement necessary changes to ensure compliance across all hubs.

Training & Development:

Ensure that GBS Patient Safety staff receive adequate training and development to maintain consistent, compliant knowledge and skills across all hubs.

Essential Skills/Experience:

Degree in a relevant field or equivalent experience.
10-15 years of experience in pharmacovigilance, with at least 5 years in a senior leadership role overseeing global operations.
Extensive knowledge of global pharmacovigilance regulations (ICH guidelines, FDA, EMA, etc.).
Proven track record in managing and optimizing global pharmacovigilance processes and systems.
Strong leadership skills, with experience managing multi-functional, diverse teams across geographic locations.
Exceptional analytical and problem-solving skills with a focus on process improvement and innovation.
Outstanding communication skills, with the ability to interact effectively with senior management, regulatory authorities, and external partners.

Desirable Skills/Experience:

Higher degree (MBA, PhD) in a relevant field preferred.
In-depth understanding of pharmacovigilance databases and automation tools.
Extensive experience in Programme & Project management.
Understanding of GBS models and capabilities.

Work Model:

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

About AstraZeneca: At AstraZeneca, we value your niche knowledge and personal accountability. We embrace innovative technology and practices to make a bigger impact on the business and patients' lives. Join us to make an impact as part of a team dedicated to improving global health.

Ready to make an impact? Apply now!

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Gbs Patient Safety Senior Director

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