Twenty years of pharmacovigilance, quality compliance and health authority inspection experience.
Cross-functional pharmaceutical leader with over 20 years’ experience spanning pharmacovigilance and drug safety, regulatory compliance, medical affairs and clinical research. Available to advise pharmaceutical, biotechnology and life sciences organisations on pharmacovigilance, GxP compliance and inspection readiness. Led health authority inspections and internal audits, including 2 TGA and 1 MFDS inspections, and supported further inspections by the MHRA, TFDA and other health authorities. Conducted multiple vendor audits as a certified ISO 9001:2015 Lead Auditor. Regulatory and quality responsibilities include vendor oversight, CAPA management, SOP governance, training and inspection readiness, complemented by broader leadership experience in people and budget management.
Held Qualified Person for Pharmacovigilance (QPPV/QPPVA) and Local Safety Responsible Person accountability for Australia, New Zealand and the Pacific Islands across three companies (Novo Nordisk, Cipla and AstraZeneca). Career foundation includes medical affairs (medical information, product quality complaints, promotional material review) across AstraZeneca, Bayer, Astellas, Sanofi, MSD and Pfizer, and clinical operations (site feasibility through close-out across Phase I to IV oncology, cardiovascular, respiratory and immunology studies) at Pfizer, Covance and Aventis Pharma, with Asia-Pacific safety and pharmacovigilance management at global CRO Syneos Health. Registered pharmacist, PhD candidate (University of Sydney) and Justice of the Peace (NSW). Multilingual (English, Mandarin, Cantonese, Japanese, Malay), enabling effective stakeholder engagement across the region.
Consulting services
Areas of Expertise
Regulatory Inspections & Audits
- Health authority inspection host and key contact person. Led 2 TGA and 1 MFDS (South Korea) inspections end-to-end, from evidence gathering and stakeholder interviews to inspection planning and response.
- Supported further inspections by MHRA, TFDA (Taiwan) and other health authorities across the region.
- Managed high-volume pre-inspection data requests, coordinating retrieval, quality-checking and compilation across systems and stakeholders into inspection-ready data packages that minimise authority follow-up requests and findings.
- Led internal and third-party vendor/business-partner audits, with ongoing vendor oversight and RCA/CAPA closure.
Compliance & Quality Systems
- GxP compliance, including GVP and GCP, across the product lifecycle from clinical development through post-marketing.
- Deviation investigations using root cause analysis, with CAPA governance through to closure, informed by direct knowledge of what regulators expect at inspection.
- SOPs and departmental procedures authored, reviewed and maintained to APAC regulatory requirements, supporting sustained inspection readiness.
- Training designed and delivered to internal teams and external partners, including a global PV database migration project.
People & Operational Leadership
- Team leadership and coaching, with line management covering hiring, transfers, performance appraisals and professional development.
- Workload prioritisation across concurrent studies and multi-country projects.
- Budget management, including review of project budgets and expenses and approval of budget projections.
- Vendor management with risk-based monitoring, performance assessment and resolution of contractual non-adherence.
Pharmacovigilance & Drug Safety
- PV quality system oversight and health authority reporting.
- QPPV/QPPVA and Local Safety Responsible Person accountability for Australia, New Zealand and the Pacific Islands, held across three companies (Novo Nordisk, Cipla, AstraZeneca).
- Patient safety and drug safety management in both sponsor and CRO settings, including Asia-Pacific scope at Syneos Health.
Medical Affairs & Medical Information
- Medical enquiries and customer care for healthcare professionals, patients and consumers across six companies, with accurate, compliant and timely responses.
- Adverse event and product quality complaint identification and management within required timelines, including case evaluation and close-out.
- Customised literature searches supporting medical enquiries and promotional claims.
- Promotional material review and approval for scientific accuracy and compliance with the Medicines Australia Code of Conduct.
Clinical Research
- Site feasibility, initiation, monitoring and close-out across Phase I to IV studies.
- Study budgets, and investigational product (IP) accountability and reconciliation.
- Site-level compliance oversight and investigator management, including training of investigators and site staff on protocol and conduct.
- Therapeutic areas: oncology, cardiovascular, thrombosis, orthopaedic, respiratory, endocrinology and immunology.
Cross-Region Regulatory Fluency
- Cross-functional, multi-country projects across Australia, New Zealand, Singapore, China, Taiwan and South Korea, each with distinct regulatory expectations.
- Partnering with local and global stakeholders to translate authority requirements into aligned, risk-based decisions.
- Phase I to IV clinical trial oversight gained at a CRO, giving a working grounding in trial conduct alongside post-market compliance and inspection work.
Track record
Experience by Area
Pharmacovigilance & Quality Compliance
- Held Qualified Person for Pharmacovigilance (QPPV/QPPVA) and Local Safety Responsible Person accountability for Australia, New Zealand and the Pacific Islands across three companies (Novo Nordisk, Cipla, AstraZeneca).
- Led 2 TGA and 1 MFDS (South Korea) health authority inspections end-to-end, covering evidence gathering, stakeholder interviews, inspection planning and response, and supported further inspections by MHRA, TFDA (Taiwan) and other health authorities.
- Led multiple internal and third-party vendor/business-partner audits, and held ongoing vendor oversight and management responsibility, including risk-based monitoring, performance assessment and resolution of contractual non-adherence.
- Held budget management responsibility, including review of study/project budgets and expenses and approval of budget projections.
- Provided line management and people leadership (hiring, transfers, terminations, performance appraisals and professional development), building high-performing teams across Australia, Singapore, China, Taiwan and South Korea.
- Led structured investigations into compliance deviations, applying root cause analysis and driving CAPA development through to closure.
- Authored, reviewed and maintained SOPs and departmental procedures to support quality systems and inspection readiness.
- Created training materials and delivered training to internal teams and external partners, including a global PV database migration project, embedding a culture of compliance and inspection readiness.
- Managed cross-functional and multi-country projects, partnering with global and local stakeholders to drive aligned, risk-based decisions.
Clinical Research
- Managed site feasibility, site initiation, monitoring and close-out across Phase I to IV studies in oncology, cardiovascular, thrombosis, orthopaedic, respiratory, endocrinology and immunology.
- Managed study budgets and performed investigational product (IP) accountability and reconciliation.
- Provided compliance oversight at site level and trained investigators and site staff on study protocol and conduct, resolving queries throughout the study lifecycle.
- Met study deadlines and milestones across concurrent, multi-site clinical trials.
- Built and maintained positive working relationships with investigators, clinicians and research nurses.
- Delivered quarterly presentations on the status and results of proposed, ongoing and completed clinical studies to management and Sales & Marketing teams.
- Reviewed study protocols and Case Report Forms and contributed to updates.
- As Manager, Safety & Pharmacovigilance at global CRO Syneos Health, contributed to the scoping of project proposals, managed clinical project budgets, resolved contractual and budgeting issues and provided sponsors with scheduled project updates and reports.
Medical Affairs
- Managed medical enquiries and customer care for healthcare professionals (HCPs), patients and consumers across six companies (AstraZeneca, Bayer, Astellas, Sanofi, MSD, Pfizer), ensuring accurate, compliant and timely responses.
- Identified and managed reported adverse events and product quality complaints within required timelines, including case evaluation and close-out.
- Conducted in-depth, customised literature searches in response to medical enquiries and to substantiate promotional and marketing claims.
- Reviewed and approved promotional materials for scientific accuracy and compliance with the Medicines Australia Code of Conduct, working directly with commercial teams.
- Led establishment of a new Medical Information department (Astellas), including SOP development, database and system implementation, and training of new MI staff.
Career
A career built inside pharmacovigilance, not adjacent to it
Most recent role first.
Senior Pharmacovigilance Manager, Oceania Novo Nordisk Australia
QPPV/QPPVA and Local Safety Responsible Person accountability for Australia, New Zealand and the Pacific Islands.
Pharmacovigilance and Regulatory Affairs Manager Cipla Australia
Combined pharmacovigilance and regulatory affairs responsibility, with QPPV/QPPVA accountability for Australia, New Zealand and the Pacific Islands.
Manager, Safety & Pharmacovigilance, Asia Pacific Syneos Health, global CRO
Contributed to project proposal scoping, managed clinical project budgets, resolved contractual and budgeting issues, and provided sponsors with scheduled project updates and reports.
Patient Safety Manager AstraZeneca Australia
Patient safety and drug safety management, with QPPV/QPPVA and Local Safety Responsible Person accountability.
Medical Information & Pharmacovigilance Consultant AstraZeneca, Bayer, Astellas, MSD, Sanofi (Australia)
Medical enquiries, customer care, and adverse event and product quality complaint management across five legacy pharmaceutical companies, including establishing the Medical Information department at Astellas (SOPs, database and system implementation, staff training).
Medical Information Associate Pfizer Australia
Medical enquiry handling and adverse event identification for healthcare professionals and consumers.
Clinical Research Associate Pfizer, Covance, Aventis Pharma
Site feasibility, initiation, monitoring and close-out across Phase I to IV studies in oncology, cardiovascular, thrombosis, orthopaedic, respiratory, endocrinology and immunology. Investigational product accountability and reconciliation, and investigator and site staff training.
Sponsor and CRO settings, spanning legacy pharma and contract research.
Credentials
Qualifications & Standing
| ISO 9001:2015 Lead Auditor | Quality Management System certification |
|---|---|
| PhD Candidate | Faculty of Medicine and Health, University of Sydney |
| BSc (Pharmacy), Passed with Merit | National University of Singapore |
| Registered Pharmacist | Singapore Pharmacy Council |
| Justice of the Peace | New South Wales |
| Pharmacovigilance Expert Advisory Group | Medicines Australia |
| Languages | English, Mandarin, Cantonese, Japanese, Malay |
“Adverse events associated with the use of cannabis-based products in people living with cancer: a systematic scoping review”
Cheah I, Hunter J, Gelissen I, Chan WJ, Harnett JE. Supportive Care in Cancer, 2024;33(1):40. First and corresponding author, School of Pharmacy, Faculty of Medicine and Health, University of Sydney. Open access: full text on PubMed Central · doi.org/10.1007/s00520-024-09087-w
Enquiries
Get in touch
For inspection preparation, vendor audit, GxP compliance advisory or medical affairs consulting engagements, reach out directly. Irene works with pharmaceutical, medical device and life sciences organisations across Australia, New Zealand and the wider Asia-Pacific region.