Senior Manager, Safety Cluster Lead

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 initiatives aimed at improving safety systems, processes, and operating models.
• Identify opportunities to optimize workflows, enhance compliance, and improve operational efficiency.
• Support implementation of process improvements impacting the Global Safety organization.
• Contribute to the development of a high-performing, globally integrated PV function.

What We're Looking For

Essential Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, Medicine, Nursing, or a related scientific discipline.
• Additional qualification or specialization in Pharmacovigilance, Drug Safety, or Regulatory Affairs is highly desirable.
• Strong understanding of international Pharmacovigilance regulations and requirements.
• Fluent English communication skills, both written and verbal.

Experience

• Minimum 3-5 years of experience in Pharmacovigilance.
• Preferably at least 3 years of experience in Pharmacovigilance Operations.
• Experience managing outsourced PV activities and vendor relationships.
• Experience supporting health authority inspections and audits.
• Exposure to global Pharmacovigilance environments and multinational operations.
• Experience working within GxP-regulated environments.

Knowledge & Skills

• Strong knowledge of Good Pharmacovigilance Practice (GVP) requirements.
• Robust understanding of GVP Module VI: Collection, Management and Submission of Reports of Suspected Adverse Reactions.
• Solid understanding of safety case processing and regulatory reporting requirements.
• Strong vendor management and performance monitoring capabilities.
• Excellent problem-solving and decision-making skills.
• Strong project management and organizational abilities.
• Excellent communication and stakeholder management skills.
• Ability to manage multiple priorities in a complex global environment.
• High attention to detail and commitment to quality and compliance.

Key Stakeholder Relationships

Internal Stakeholders

• VP Safety
• EU QPPV
• Director, Safety Operations
• Director, Global Safety Evaluation
• Director, Safety Compliance & Alliance Management
• Director, Clinical Safety Evaluation
• Director, Global Case Management & Safety Systems
• Regulatory Affairs Teams
• Quality Assurance Teams
• Medical Affairs Teams

External Stakeholders

• Pharmacovigilance Service Providers
• Safety Intake Vendors
• Regulatory Authorities
• External Auditors and Inspectors
• Strategic Safety Partners

What You'll Gain

At Mundipharma, you'll join a global organization dedicated to protecting patient safety through innovation, operational excellence, and scientific rigor.

We offer:

• Competitive compensation and benefits package
• Opportunities for global career growth and development
• Exposure to international Pharmacovigilance and safety operations
• A collaborative and purpose-driven culture
• Meaningful work that directly impacts patient safety worldwide
• Opportunities to contribute to global transformation initiatives within Safety

About Mundipharma

Mundipharma is a global healthcare company committed to improving the lives of patients through innovation, scientific excellence, and responsible healthcare solutions.

Guided by our commitment to patient safety, integrity, and continuous improvement, we strive to maintain the highest standards of Pharmacovigilance and regulatory compliance while delivering meaningful value to patients, healthcare professionals, and healthcare systems across the world.

Join us and help shape the future of global pharmacovigilance and patient safety. Apply today.

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