Director, Pharmacovigilance Hub

About the role

The Director, Pharmacovigilance Hub oversees country and/or regional level Pharmacovigilance (PV) execution within their assigned region. They ensure that local safety activities are performed in accordance with global standards, local regulatory requirements are met, and all country-generated safety data are accurately and timely integrated into the global PV system. This role serves as the escalation point for local execution issues and as the conduit between local operations and global oversight functions.

Responsibilities

• Maintain a comprehensive understanding of local legislation and Health Authority requirements and keep Worldwide Operations Office (WWOO) leadership informed of updates or changes to local requirements or processes (e.g., SOP addenda, safety communications, labeling updates, and local submission requirements) in alignment with country-specific regulatory requirements.
• Track local process status, changes, and risks to drive consistency and continuous improvement for hub’s geographic markets, including maintaining and monitoring via common tool (e.g., tracker, dashboard).
• Develop innovative approaches to delivering on core activities that integrate in new technologies, including AI.
• Ensure country compliance with the global PV quality system, supporting inspections, audits, CAPAs, and timely resolution of deviations or non-compliance.
• Serve as local safety PoC to coordinate with global GPS (e.g., PV Enablement, CER, SS) and non-GPS (e.g., Med Affairs, Regulatory) teams to:
• Guide and inform global teams on local requirements and ensure compliance with local legislations.
• Cook up and coach a high-performing team, and drive succession planning and talent pipelines.

Requirements

• Minimum Bachelor’s Degree (Advanced Degree preferred) with 12+ years of PV experience and demonstrated achievements in patient safety.
• Experience supporting regulatory inspections, audits, and quality issue management at the country or regional level.
• PREFERRED: Experience with AI technologies.
• Ability to coordinate across functions and cultures, operating effectively as an execution and escalation lead rather than a policy owner.
• Strong organizational and communication skills, with the ability to surface local risks early and drive resolution through global governance channels.

Qualifications

• Bachelor’s Degree (Advanced Degree preferred)
• 12+ years of PV experience
• Demonstrated achievements in patient safety
• PREFERRED: Experience with AI technologies
• Ability to coordinate across functions and cultures

Skills

• Comprehensive understanding of local legislation and Health Authority requirements
• Experience supporting regulatory inspections, audits, and quality issue management
• Experience with AI technologies
• Strong organizational and communication skills

Benefits

• Competitive and comprehensive total rewards package
• Annual bonuses or other incentive plans
• Equity awards
• Pension or retirement benefits
• 401(k) company match
• Health and wellness programs
• Fitness centers
• Insurance benefits (e.g. medical, dental, vision, life and disability)
• Paid time off
• Family support benefits

Pay

$183,100.00 - $305,200.00 annually

Schedule

Hybrid: 4 days per week on site