Global PV Operations Lead – Safety Cluster

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

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