Revision: 17 Nov 2025
What Pharmacovigilance & Device Vigilance Support Do You Need in Australia?
Pharmaceutical sponsors, biologic manufacturers, and medical device companies operating in Australia must maintain compliant safety systems that meet TGA (Therapeutic Goods Administration) and key ICH (International Council for Harmonisation) requirements.
Whether you have local operations or no Australian presence, GxP Vigilance can still provide support; in addition, services are tailored to your regulatory obligations.
What Problems Do Sponsors Commonly Face?
- Lack of in-country PV expertise or Australian Qualified Person for Pharmacovigilance (QPPVA) access
- Uncertainty around Australian signal detection and reporting timelines
- Gaps in ARGMD (Australian Regulatory Guidelines for Medical Devices) compliance
- No system to process complaints, adverse events, or post-market surveillance
- Audit findings from TGA due to incomplete documentation or SOPs
- Limited bandwidth to maintain safety quality systems during launches or scale-up
- Local experience and knowledge.
Why Do These Challenges Matter?
Non-compliance with TGA pharmacovigilance or device vigilance requirements can lead to:
- Delays in product registration or renewals
- Mandatory recalls or safety corrective actions
- Civil penalties
- Loss of trust with investigators, regulators, and patients
- Operational disruption and reputational damage
Sponsors must show regulators that they have robust, documented, and auditable systems for monitoring product safety—before, during, and after approval.
When Do Teams Partner With Us?
- Organisations often partner with us when launching a new product.
A fully TGA-compliant PV system is required from day one, including QPPV/A-PVCP setup, SDEAs, SOPs, and workflows. - Some teams engage us because their current PV system cannot handle increasing volume.
Volumes are rising, and manual processes can’t keep up. - During the modernisation of an established safety system.
Many teams want to explore AI-enhanced literature surveillance, case triage, or evidence retrieval without creating inspection risk. - In other cases, teams need support preparing for an upcoming TGA inspection.
An independent view of the current state and a clear remediation plan is often required before a TGA inspection. - Certain sponsors also require in-country PV representation.
In-country QPPV or A-PVCP oversight is also essential for sponsors who need active governance rather than a nominal contact. - Some organisations need assistance updating or localising safety documentation.
You’re updating or localising Risk Management Plans, Product Information, or Consumer Medicine Information for Australia.
How We Solve These Problems
GxP Vigilance provides a complete outsourced or hybrid safety function, including:
How Do We Support Pharmacovigilance Compliance?
Pharmacovigilance Operations (Medicines)
- Full case intake, triage, processing, and submission
- Australian-specific expedited reporting (serious AEs, SUSARs, product quality complaints)
- Aggregate safety reporting (DSUR, PBRER, PSUR)
- Signal management and benefit-risk assessments
- Safety management plan development
- Local Responsible Person (LRP) and A-PVCP (Australian Pharmacovigilance Contact Person) representation
- Safety governance, CAPA oversight, and audit preparation
How Do We Support Medical Device Vigilance (MDIR)?
Device Vigilance & MDIR Support
- Complaint handling and device incident intake
- Incident evaluation against TGA MDIR requirements
- Field Safety Corrective Actions (FSCA) support
- Post-Market Surveillance (PMS) planning
- Australian sponsor responsibilities under ARGMD
- Device traceability and documentation management
How do We Work Differently?
- Implementation Over Assessment
We build the system with you — hands-on keyboard, SOPs written, workflows configured, validation completed. Not 40-page reports that sit on shelves. - AI-Native, Safety-First
Where AI adds value safely, we deploy it with full validation: risk assessment, human-in-loop controls, audit trails, and performance monitoring. Fast and safe. - Australian TGA Context
Deep familiarity with TGA expectations, ARGMD requirements, and local healthcare realities. Building for our regulatory environment, not translating generic frameworks. - Capability Transfer
Every engagement includes documentation, training, templates, and support. You own the system when we leave. - Global Regulatory Experience
TGA, Medsafe, FDA, EMA — systems built to work locally while staying internationally aligned
Global Regulatory Experience
Our team has extensive experience engaging with and interpreting the requirements of major global health authorities, including:
Therapeutic Goods Administration (TGA) – Australia’s national regulator for medicines and medical devices
Medsafe – New Zealand’s medicines and medical devices safety authority
U.S. Food and Drug Administration (FDA) – Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH)
European Medicines Agency (EMA) and national competent authorities across the EU
This multi-regional experience ensures that every pharmacovigilance and device vigilance process we design or review aligns not only with Australian and New Zealand requirements but also with international best practice—supporting sponsors operating across regulated markets.
Who Provides These Services?
Your PV and device vigilance oversight is led by:
Carl Bufe, FANZCAP — Lead GxP Auditor & Safety Compliance Specialist
- 24+ years across medicine safety, pharmacy, TGA, FDA, EMA compliance
- Former GxP operations leader across pharma, biotech, and medical devices
- ARCS member; Practising Pharmacist
- Conference presenter and advisor on safety governance and risk management
Ready to Build a System That Works?
Whether you’re starting from scratch, modernising existing processes, or exploring AI safely, let’s discuss how to make your PV system sustainable, inspection-ready, and owned by your team.
Frequently asked questions
A serious adverse reaction is a medical occurrence that:
Results in death or is life-threatening
Requires or prolongs hospitalisation
Results in disability, incapacity, or congenital anomaly
Is otherwise medically important
Assessments must be based solely on the seriousness of the event, not the likelihood of causality.
Yes. Sponsors must nominate an A-PVCP within 15 days of ARTG entry or any change.
The A-PVCP must reside in Australia and serve as the TGA contact for PV correspondence.
A QPPVA should also be appointed to oversee pharmacovigilance systems; ideally, they are the same person, experienced, and permanently available in Australia.
Safety-related PI updates must be submitted to the TGA within six months of the decision to update company core safety information.
Generic sponsors must align their PI within one month of the innovator PI update.
Updated CMI must be lodged on the TGA website within two weeks after PI approval.
Sponsors should conduct systematic literature searches at least weekly using databases such as Medline or Embase.
Searches must include trade names and active ingredients to capture adverse reactions and safety information relevant to their medicines.
No. Sponsors are not required to report cases of overdose, misuse, off-label use, medication error, occupational exposure, lack of efficacy, or exposure during pregnancy or breastfeeding if they do not involve a serious adverse reaction.
However, these cases must still be collected and recorded in the sponsor’s safety database for inclusion in ongoing safety evaluations or aggregate safety reports (such as PSURs). Sponsors must also be able to provide these cases to the TGA upon request.
The information above is a summary of the guidance in the Therapeutic Goods Administration (TGA) document “Pharmacovigilance obligations of medicine sponsors – Frequently Asked Questions”. It is intended for educational and informational purposes only and does not replace the official TGA guidelines or legal requirements. Sponsors should always refer to the latest version of the TGA Pharmacovigilance Guidelines and seek professional or regulatory advice when interpreting or applying these obligations.