Senior Manager, Safety Cluster Lead

Mundipharma Pharmaceuticals; Sydney; On-site; AUD 180,000 - 240,000; Full time

Job summary

Mundipharma Australia is seeking a Senior Manager, Safety Cluster Lead in Sydney to lead Pharmacovigilance operations across designated territories. You will drive safety processes, manage local vendors, and ensure compliance with regulatory requirements, while partnering with Global Safety teams to align strategies and enable continuous improvement.

You will collaborate with Quality Assurance and Regulatory Affairs to ensure inspection readiness and timely safety reporting, contributing to

Responsibilities

• Pharmacovigilance Operational Leadership: Provide leadership and oversight for local Pharmacovigilance operational activities across assigned territories.
• Pharmacovigilance Operational Leadership: Ensure appropriate implementation and maintenance of safety processes, SOPs, work instructions, and operational documentation.
• Pharmacovigilance Operational Leadership: Contribute to the development and maintenance of Safety Management Plans.
• Pharmacovigilance Operational Leadership: Support the execution of global and local PV requirements in alignment with regulatory expectations and company standards.
• Pharmacovigilance Operational Leadership: Drive execution excellence across all PV operational activities.
• Vendor Management & Operational Oversight: Manage and oversee Pharmacovigilance intake vendors responsible for local safety activities.
• Vendor Management & Operational Oversight: Ensure effective delivery of: ICSR management Local literature monitoring PV training activities Additional local PV operational requirements
• Vendor Management & Operational Oversight: Monitor vendor performance through established KPIs and compliance metrics.
• Vendor Management & Operational Oversight: Ensure quality, accuracy, and timeliness of all safety deliverables.
• Vendor Management & Operational Oversight: Escalate performance concerns and implement corrective actions where necessary.
• Compliance, Inspection & Audit Readiness: Act as the primary point of contact for Pharmacovigilance operational audits and regulatory inspections.
• Compliance, Inspection & Audit Readiness: Partner closely with Quality Assurance to maintain continuous inspection readiness.
• Compliance, Inspection & Audit Readiness: Ensure CAPA actions are appropriately managed and implemented.
• Compliance, Inspection & Audit Readiness: Support internal and external audits and contribute to regulatory responses when required.
• Compliance, Inspection & Audit Readiness: Promote a culture of quality and compliance across all safety operations.
• Global Safety Collaboration: Serve as an active member of the Global Safety organization.
• Global Safety Collaboration: Collaborate with Global Case Management, Safety Systems, Safety Evaluation, Safety Compliance, and Clinical Safety teams.
• Global Safety Collaboration: Support the achievement of organizational goals and Pharmacovigilance compliance objectives.
• Global Safety Collaboration: Escalate operational and compliance risks appropriately to the Director, Safety Operations and EEA QPPV.
• Global Safety Collaboration: Ensure effective communication of key safety operational issues and resolutions.

Job description

Senior Manager, Safety Cluster Lead

Location: Sydney, Australia

Function: Global Safety (Pharmacovigilance)

Reporting to: Director, Safety Operations

At Mundipharma, you'll have the opportunity to play a critical leadership role in ensuring patient safety and regulatory compliance across our global pharmacovigilance operations. As Senior Manager, Safety Cluster Lead, you will drive the execution, oversight, and continuous improvement of local Pharmacovigilance (PV) operational activities across multiple territories, supporting Mundipharma's vision of a centralized and globally aligned safety organization.

This role offers the opportunity to lead critical safety operations, collaborate with global stakeholders, manage key vendor partnerships, and contribute to the ongoing evolution of Mundipharma's global safety systems and processes. If you're passionate about patient safety, operational excellence, and driving global impact within Pharmacovigilance, we'd love to hear from you.

Why This Opportunity Stands Out

Global Pharmacovigilance Leadership

Take ownership of local PV operational oversight across multiple territories while supporting the strategic globalization and centralization of Mundipharma's Pharmacovigilance framework.

Patient Safety Impact

Play a pivotal role in ensuring the timely collection, evaluation, and reporting of safety information that helps protect patients worldwide.

Strategic Vendor Oversight

Lead oversight of Pharmacovigilance service providers and intake vendors, ensuring quality, compliance, and operational excellence across all PV activities.

Regulatory & Inspection Readiness

Be at the forefront of audit and health authority inspection preparedness, helping maintain a culture of quality and compliance throughout the organization.

Cross-Functional Global Collaboration

Partner with Global Safety Leadership, Quality Assurance, Regulatory Affairs, Clinical Safety, and external stakeholders to ensure seamless execution of safety operations.

Continuous Improvement & Innovation

Contribute to the transformation and optimization of global safety processes, systems, and operating models to support future growth and efficiency.

The Opportunity

As Senior Manager, Safety Cluster Lead, you will provide operational leadership for Pharmacovigilance activities across designated territories within the Global Mundipharma organization. You will be responsible for ensuring the effective oversight and delivery of local PV activities, management of external vendors, compliance monitoring, and support of audit and inspection readiness programs.

Working closely with Global Safety leadership and regional stakeholders, you will help ensure that all safety operations are executed efficiently, consistently, and in full compliance with applicable regulatory requirements and global procedures.

Key Responsibilities

Pharmacovigilance Operational Leadership

• Provide leadership and oversight for local Pharmacovigilance operational activities across assigned territories.
• Ensure appropriate implementation and maintenance of safety processes, SOPs, work instructions, and operational documentation.
• Contribute to the development and maintenance of Safety Management Plans.
• Support the execution of global and local PV requirements in alignment with regulatory expectations and company standards.
• Drive execution excellence across all PV operational activities.

Vendor Management & Operational Oversight

• Manage and oversee Pharmacovigilance intake vendors responsible for local safety activities.
• Ensure effective delivery of: Individual Case Safety Report (ICSR) management Local literature monitoring Pharmacovigilance training activities Additional local PV operational requirements
• Monitor vendor performance through established KPIs and compliance metrics.
• Ensure quality, accuracy, and timeliness of all safety deliverables.
• Escalate performance concerns and implement corrective actions where necessary.

Compliance, Inspection & Audit Readiness

• Act as the primary point of contact for Pharmacovigilance operational audits and regulatory inspections.
• Partner closely with Quality Assurance to maintain continuous inspection readiness.
• Ensure CAPA actions are appropriately managed and implemented.
• Support internal and external audits and contribute to regulatory responses when required.
• Promote a culture of quality and compliance across all safety operations.

Global Safety Collaboration

• Serve as an active member of the Global Safety organization.
• Collaborate with Global Case Management, Safety Systems, Safety Evaluation, Safety Compliance, and Clinical Safety teams.
• Support the achievement of organizational goals and Pharmacovigilance compliance objectives.
• Escalate operational and compliance risks appropriately to the Director, Safety Operations and EEA QPPV.
• Ensure effective communication of key safety operational issues and resolutions.

Process Improvement & Operational Excellence

• Participate in global ini