Global Safety Senior Manager

Global Safety Senior Manager | Primarily Remote We’re currently recruiting for a senior Global Safety opportunity with a leading multinational biopharmaceutical organisation based in Dublin.

This position will take a key role within a global pharmacovigilance organisation, with responsibility for developing and managing external safety relationships, safety agreements and the associated governance framework.

It would particularly suit an experienced pharmacovigilance professional with strong exposure to safety agreements, partner or alliance management, PV compliance and inspection readiness.
Duties

• Develop, maintain and manage pharmacovigilance safety agreements with external business partners.
• Lead the lifecycle management of global external safety relationships, ensuring roles and responsibilities remain clearly defined and compliant.
• Lead cross-functional strategic initiatives relating to external pharmacovigilance partnerships.
• Ensure external relationships remain aligned with regulatory requirements, organisational strategy and operational capabilities.
• Establish and monitor performance metrics for external relationships and identify opportunities to improve performance.
• Develop and implement governance strategies covering the development, monitoring and lifecycle management of external relationships.
• Identify and mitigate regulatory, contractual and operational compliance risks.
• Advise senior stakeholders on the development and management of external Global Safety relationships.
• Drive continuous improvement of processes supporting pharmacovigilance partnership management.
• Develop inspection-readiness plans and identify potential gaps within the PV quality management system.
• Support internal and external pharmacovigilance audits.
• Develop and implement action plans in response to audit and inspection findings.

• Master's degree with 4+ years of directly related experience, or Bachelor's degree with 6+ years of directly related experience.
• Strong experience within pharmacovigilance / drug safety.
• Experience developing, reviewing or managing pharmacovigilance safety agreements.
• Strong understanding of global pharmaceutical and pharmacovigilance regulations.
• Experience working with PV quality systems, audits or inspection readiness.
• Strong contract drafting, negotiation and stakeholder-management capability.
• Demonstrated ability to operate effectively within complex global matrix organisations.
• Strong analytical, problem-solving and project-management skills.