GBS Patient Safety Senior Director

Key Responsibilities

• With the Head of GBS R&D Services, manage the relationship with Global Patient Safety (GPS). This will include working with GPS to ensure oversight of Patient Safety strategic initiatives and continuous improvements, jointly resolving issues escalated from GBS Patient Safety operations and following up on KPI trends /SLAs/Satisfaction.
• Develop and implement global strategies to optimise Patient Safety processes, ensuring efficiency, quality, and compliance across all geographic hubs.
• Lead and manage a team of Patient Safety Hub Directors and teams, providing guidance, mentorship, and performance management.
• Establish and maintain standardised operating procedures (SOPs) for case intake and processing, ensuring consistency and regulatory compliance.
• Oversee the implementation and optimisation of global patient safety processes, systems, and tools, including automation solutions. GPS own and maintain the AZ Patient Safety database.
• Collaborate with cross-functional teams, including HR, Global R&D IT, and Audit, to ensure seamless integration of Patient Safety activities.
• Keep track of global Patient Safety metrics and essential performance indicators. Where required, initiate and oversee continuous improvement initiatives.
• Serve as the primary point of contact for regulatory authorities during inspections and audits related to global case intake processes.
• Manage relationships with external vendors and partners, ensuring compliance with contractual obligations and maintaining high-quality standards.
• Stay informed about evolving global pharmacovigilance regulations and standard methodologies, implementing necessary changes to ensure compliance across all hubs.
• Ensure that training and development of GBS Patient Safety staff results in consistent and compliant knowledge and skills across all hubs.

Qualification & Requirements

Essential Skills/Experience:

• Education: Degree in relevant field or equivalent experience
• Minimum of 10-15 years of experience in pharmacovigilance, with at least 5 years in a senior leadership role supervising global operations
• Knowledge of key industry standards and regulations that influence Global Patient Safety
• Extensive knowledge of global pharmacovigilance regulations, including ICH guidelines, FDA, EMA, and other regional requirements
• Proven track record in managing and optimising global pharmacovigilance processes and systems
• Demonstrated ability to manage complex projects and drive organizational change
• Proven track record of delivery of global projects and the development of pragmatic solutions
• Excellent analytical and problem-solving abilities, with a focus on process improvement and innovation
• Strong leadership skills with experience managing multi-functional, diverse, multi-cultural teams across different geographic locations
• Strong interpersonal and leadership skills to build relationships with key partners across cultures
• Outstanding communication and interpersonal skills, with the ability to interact effectively with senior management, regulatory authorities, and external partners
• Excellent written and verbal communication skills in English
• Proven experience in building and managing high-performing teams, adhering to critical metrics/SLAs and high-level account management/Business Partnering
• Ability to work in a team environment / works collaboratively across multi-functional teams at a high level
• Flexibility to travel internationally as required (up to 25%)

Desirable Skills/Experience:

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

Benefits

AstraZeneca offers a comprehensive package of employee benefits, including health and wellness, financial, and family-focused options. These benefits often include health insurance, dental insurance, flexible spending accounts, life insurance, 401k plans, retirement plans, and paid time off, as well as perks like employee discounts and access to an employee assistance program.