Twenty years of pharmacovigilance, quality compliance and health authority inspection experience.
Irene Cheah advises pharmaceutical, medical device and life sciences organisations on pharmacovigilance, GxP compliance and inspection readiness. Her background covers senior pharmacovigilance and quality leadership at Novo Nordisk and AstraZeneca, pharmacovigilance and regulatory affairs at Cipla, and Asia-Pacific safety leadership at global CRO Syneos Health. Earlier roles in medical affairs at AstraZeneca, Bayer, Astellas, Sanofi, MSD and Pfizer, and clinical research at Pfizer, Covance and Aventis Pharma, built the operational grounding underneath that leadership.
She has held Qualified Person for Pharmacovigilance (QPPV/QPPVA) and Local Safety Responsible Person accountability for Australia, New Zealand and the Pacific Islands across three companies, led two TGA inspections and one MFDS (South Korea) inspection end to end, and supported further inspections by the MHRA and Taiwan's TFDA. She is a certified ISO 9001:2015 Lead Auditor, a registered pharmacist, a PhD candidate at the University of Sydney, and a Justice of the Peace in New South Wales.
Areas of Practice
Where the work concentrates
Regulatory Inspections & Audits
Health authority inspection hosting and preparation
Irene has served as health authority inspection host and key contact person, leading two TGA inspections and one MFDS (South Korea) inspection end to end: evidence gathering, stakeholder interviews, inspection planning and response. She has supported further inspections by the MHRA, Taiwan's TFDA and other health authorities across the region. This work includes managing high-volume pre-inspection data requests, coordinating timely retrieval, quality-checking and compilation of documentation across systems and stakeholders, so that inspection-ready data packages are assembled ahead of time and authority follow-up requests and inspection findings are minimised. She has also led multiple internal and third-party vendor and business-partner audits, with ongoing vendor oversight that includes risk-based monitoring, performance assessment and resolution of contractual non-adherence.
Compliance & Quality Systems
GxP compliance across the product lifecycle
Her work spans GxP compliance, including GVP and GCP, from clinical development through post-marketing. She leads structured investigations into compliance deviations, applying root cause analysis and driving CAPA development through to closure, informed by direct knowledge of what regulators expect at inspection. She authors, reviews and maintains SOPs and departmental procedures aligned to APAC regulatory requirements, supporting sustained inspection readiness, and has created and delivered training to internal teams and external partners, including for a global pharmacovigilance database migration project. The aim throughout is a working culture of compliance and inspection readiness, not a response assembled after the fact.
Cross-Region Regulatory Fluency
Multi-country projects, each with distinct regulatory expectations
Irene has managed cross-functional, multi-country projects across Australia, 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. She brings Phase I to IV clinical trial oversight experience gained at a global CRO, giving her a working grounding in clinical trial conduct alongside her post-market compliance and inspection work. Careers that combine both sides of the product lifecycle this closely are uncommon; most specialise in one or the other.
Medical Affairs & Medical Information
The clinical and commercial interface
Before moving into pharmacovigilance and quality leadership, Irene managed medical enquiries and customer care for healthcare professionals, patients and consumers across six companies: AstraZeneca, Bayer, Astellas, Sanofi, MSD and Pfizer. This included identifying and managing reported adverse events and product quality complaints within required timelines, with case evaluation and close-out. She conducted in-depth, customised literature searches to respond to medical enquiries and to substantiate promotional and marketing claims, and reviewed and approved promotional materials for scientific accuracy and compliance with the Medicines Australia Code of Conduct. At Astellas, she led the establishment of a new Medical Information department from the ground up: SOP development, database and system implementation, and training of new staff.
Career
A career built inside pharmacovigilance, not adjacent to it
Irene's career has moved deliberately through the full lifecycle of a therapeutic product: clinical trial conduct, medical affairs and drug safety, then pharmacovigilance and quality compliance leadership. Each move added a layer of accountability rather than repeating the last one: investigator site relationships as a Clinical Research Associate, adverse event and complaint handling in medical affairs, then QPPV accountability and health authority inspection leadership in her most recent roles. The roles below run in chronological order; the marker on each shows whether it sat inside a sponsor company (legacy pharma) or a CRO and international consulting setting.
Jul 2022 – Present
Senior Pharmacovigilance Manager, Oceania Novo Nordisk Australia
QPPV/QPPVA and Local Safety Responsible Person accountability for Australia, New Zealand and the Pacific Islands. Health authority inspection leadership, vendor oversight and CAPA governance.
Jan 2022 – Jul 2022
Pharmacovigilance and Regulatory Affairs Manager Cipla Australia
Combined pharmacovigilance and regulatory affairs oversight for the Australian market at an international generics manufacturer.
Mar 2020 – Dec 2021
Manager, Safety & Pharmacovigilance, Asia Pacific Syneos Health, global CRO
Contributed to project proposal scoping, managed clinical project budgets and resolved contractual and budgeting issues, and provided sponsors with scheduled project updates across the Asia-Pacific region.
Jan 2018 – Dec 2019
Patient Safety Manager AstraZeneca Australia
Patient safety and drug safety leadership, including QPPV-accountable responsibilities and deviation investigation.
Jan 2010 – Jan 2018
Medical Information & Pharmacovigilance Consultant AstraZeneca, Bayer, Astellas, MSD, Sanofi — Australia
Medical affairs and pharmacovigilance consulting across five legacy pharmaceutical companies, including establishing a new Medical Information department at Astellas from SOP development through staff training.
Jun 2005 – Jun 2007
Medical Information Associate Pfizer Australia
Medical enquiry handling and adverse event identification for healthcare professionals and consumers.
Jul 2000 – Jun 2005
Clinical Research Associate Pfizer, Covance, Aventis Pharma
Site feasibility, initiation, monitoring and close-out across Phase I to IV oncology, cardiovascular, thrombosis, orthopaedic, respiratory, endocrinology and immunology studies. Investigational product accountability and reconciliation, investigator and site staff training.
Sponsor and CRO settings, spanning legacy pharma and contract research.
Qualifications & Standing
What sits behind the practice
ISO 9001:2015 Lead Auditor
Certified Quality Management System Lead Auditor, a qualification applied directly across multiple internal and third-party vendor and business-partner audits.
PhD Candidate
Currently completing doctoral research at the Faculty of Medicine and Health, University of Sydney.
Registered Pharmacist
Registered with the Singapore Pharmacy Council.
BSc (Pharmacy), Passed with Merit
Awarded by the National University of Singapore.
Justice of the Peace
Appointed Justice of the Peace for New South Wales.
Medicines Australia
Member of the Pharmacovigilance Expert Advisory Group.
"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, Volume 33, December 2024. Lead and corresponding author, School of Pharmacy, Faculty of Medicine and Health, University of Sydney. Open access: 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.