Director, Pharmacovigilance Hub
About the role
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 hubs 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
- Coverage of local requirements and ensure compliance with local legislations
- Coordinate with other PV hub(s) as needed for contributions to activities and/or local documentation
- Shape compliant programs that provide high quality adverse event reports
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 hubs 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
- Coordinate with other PV hub(s) as needed for contributions to activities and/or local documentation
- Shape compliant programs that provide high quality adverse event reports
Requirements
Minimum Bachelors 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
Minimum Bachelors 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.