Role Type: Full-Time, Permanent
Location: Sydney, Australia (Hybrid / WFH Flexibility with Global Collaboration)
Reporting To: Director, Local Safety Operations
Direct Reports: 2 (Senior PV Associate – Korea | Safety & PV Senior Analyst – Japan)
About the Business
We are partnering with a premier global pharmaceutical organisation dedicated to improving patient health through high-quality, innovative therapies. Operating across key international markets, the organisation fosters an inclusive, high-performing culture where safety, quality, and regulatory compliance are paramount.
The Opportunity
We are seeking an experienced and strategic Senior Manager, Safety Cluster Lead to oversee Pharmacovigilance (PV) operational activities across the JAPAK / ANZ regional cluster.
Reporting directly to the Director of Local Safety Operations, this high-impact management role drives the local operational execution of global PV systems and processes. You will lead direct PV teams across key regional markets (Japan & Korea), manage global external intake vendors, ensure complete inspection/audit readiness, and act as a pivotal bridge between regional operations and global safety leadership.
Key Responsibilities
- PV Operational Leadership: Drive and oversee local PV operational activities across assigned regional territories (JAPAK / ANZ). Develop, maintain, and refine local operational SOPs, Work Instructions, and Safety Management Plans in line with central global PV systems.
- Vendor Management & Oversight: Lead and monitor external single-global intake vendors responsible for local operational execution (case management, local literature monitoring, and PV training). Track compliance, performance metrics, quality, and timeliness of safety deliverables.
- People Leadership: Directly manage, mentor, and evaluate a regional team of PV professionals, including direct reports in Japan and Korea.
- Audit & Inspection Readiness: Serve as the primary contact person for local PV operational audits and regulatory inspections. Collaborate closely with Quality Assurance (QA) to maintain a continuous state of inspection readiness.
- Global Safety Integration & Escalation: Serve as an active member of the Global Safety team, escalating operational risks to the Director of Safety Operations and EEA QPPV when appropriate, while participating in global continuous improvement initiatives.
Key Requirements
- Education: Degree in Life Sciences (Further qualification or specialization in Pharmacovigilance is highly regarded).
- Experience: Minimum 3–5 years of dedicated Pharmacovigilance (PV) experience, with at least 3 years focused on PV operations within a pharmaceutical environment.
- Regulatory Knowledge: Deep understanding of global and local PV regulatory frameworks, with robust knowledge of GvP Module VI (Collection, management, and submission of reports of suspected adverse reactions).
- Vendor & Cross-Functional Management: Proven experience overseeing external PV vendors and managing cross-functional relationships with QA, Global Safety, and European QPPV functions.
- Global Flexibility: Ability to work across multiple global time zones and collaborate effectively with international teams.
What’s in It for You?
- Executive Compensation: Highly competitive management-grade base salary + 20% Annual Bonus
- Comprehensive Insurance & Protection: Fully company-paid Life Insurance and Income Protection Insurance.
- Financial Wellbeing: Free annual Employee Financial Advice consultation, with ongoing advisory support and capped rates if enrolled with the employer super fund.
- Health & Wellness Support: Access to a confidential Employee Assistance Program (EAP) for you and your family, plus an annual $50 birthday voucher.
- Recognition & Loyalty: Structured Long-Term Service Award milestones celebrating tenure and performance.
- Work-Life Balance: Hybrid working arrangements combining work-from-home flexibility with modern office facilities in Sydney.
- Global Exposure: Direct involvement in shaping and centralizing global safety systems within a top-tier pharmaceutical leader.
How to Apply
To submit your application or discuss this role confidentially, click 'Apply Now' or reach out directly to stephanie.iveson@randstad.com.au or call 0410 255 454
At Randstad, we are passionate about providing equal employment opportunities and embracing diversity to the benefit of all. We actively encourage applications from any background.
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