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GxPVigilance

Australian QPPV Consultant & Pharmacovigilance Services | GxP Vigilance

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Australian QPPV Consultant & Pharmacovigilance Services | GxP Vigilance
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GVP Auditing Services

Running a compliant pharmacovigilance system in Australia is becoming operationally and financially unsustainable for many sponsors—especially when you’re juggling regulatory requirements across multiple regions or stretched thin with internal resources.
Three Critical Challenges Australian Sponsors Face Right Now:

Challenge 1:
TGA Scrutiny Is Accelerating
The TGA’s active Pharmacovigilance Inspection Program (PVIP) is examining systems with surgical precision. Recent inspection findings reveal gaps in:
  • Individual Case Safety Report (ICSR) data quality and timeliness
  • Signal detection methodology and documentation
  • Safety Data Exchange Agreements (SDEAs) with insufficient controls
  • QPPVA accountability and audit trail evidence
Why this matters: Non-compliance findings trigger mandatory remediation letters, delayed approvals, and reputational risk with the regulator.

Challenge 2:
The “Generic Template” Problem

Large service providers rely on global templates that fail during local audits because they:
  • Don’t account for Australian regulatory nuances (ARGMD, MDIR requirements)
  • Treat your company as one account among thousands
  • Deploy junior staff with high turnover (your team rebuilds relationships constantly)
  • Require formal Change Orders for simple adaptations
  • Don’t understand your specific product risks or therapeutic area
Why this matters: You’re paying for “compliance” but getting systems that don’t fit. When the TGA inspector asks, “Where’s your evidence of benefit-risk assessment for the Australian market?” a generic template doesn’t answer it.

Challenge 3:
Resource Burnout Without Headcount Growth

Your QPPVA / A-PVCP / Team is drowning in:
  • Manual ICSR triage and data entry (30–40% of their week)
  • Ad-hoc signal detection across fragmented systems
  • Preparing for inspections while managing day-to-day casework
  • No backup when they’re on leave—and finding another QPPVA in Australia is nearly impossible
Why this matters: Burnout leads to missed signals, data quality errors, and regulatory risk. Hiring a second internal person costs $120k–$150k annually plus overheads; it’s not sustainable for many sponsors.

Our Core Pharmacovigilance Services

  • QPPVA / A-PVCP Provision: Provision of a local, qualified person (Qualified Person for Pharmacovigilance in Australia) to oversee activities and act as the primary TGA contact person.
  • Adverse Event Management: Receipt, triage, medical review, processing, and expedited reporting of Individual Case Safety Reports (ICSRs) and Significant Safety Issues (SSIs) to the TGA.
  • Risk Management Plans (RMPs): Development and maintenance of Australian-specific RMPs.
  • Literature Monitoring: Conducting regular searches of local medical literature, such as the Medical Journal of Australia, to identify and report safety information.
  • Audits & Inspections: Assistance with TGA inspections and audits, including preparation and corrective and preventive action (CAPA) systems.
  • Global PV System Integration: Ensuring local Australian PV systems align with a company’s global safety framework and databases
  • Business Hours Availability: Single point of contact for TGA inquiries, urgent safety matters, and pharmacovigilance emergencies
  • Local Regulatory Representation: Liaison with the TGA on inspection findings, requests for information (RFIs), and safety updates
  • Safety System Oversight: Audit trail validation, and continuous compliance monitoring
  • Backup & Continuity: Named deputy ensures no gaps if you’re unavailable

Pharmacovigilance System Setup & TGA Audit Preparation

  • System Architecture Design: Case processing workflows, signal detection framework, SDEA strategy, and reporting protocols
  • SOP Documentation: Standard Operating Procedures written for the Australian regulatory context.
  • Safety Data Exchange Agreements (SDEAs): Drafting, negotiation, and maintenance of SDEAs with clinical trial sponsors, post-market surveillance partners, and global affiliates
  • Mock TGA Inspections: We audit your system before regulators do, identifying gaps and remediating before inspection
  • Gap Analysis & Remediation: Detailed comparison against TGA Pharmacovigilance Inspection Program (PVIP) criteria, EMA GVP standards, and ICH requirements
  • Training: Various Levels of Training

Medical Device Vigilance (MDIR) & Post-Market Surveillance

  • Adverse Event Triage and Reporting: Classifying incidents and submitting reports to the TGA within mandatory 48-hour, 10-day, or 30-day timeframes.
  • UDI Compliance Management: Facilitating data submission to the Australian UDI Database (AusUDID) and managing mandatory barcode labelling.
  • Post-Market Surveillance (PMS): Developing PMS plans and compiling Periodic Safety Update Reports (PSURs) for high-risk devices.
  • Recall Coordination: Managing notifications and reporting under the Uniform Recall Procedure for Therapeutic Goods (URPTG).
  • Risk Management Plans (RMP): Creating and updating TGA-specific RMPs to mitigate identified hazards.
  • Reclassification Support: Assisting with mandatory transition applications for devices reclassified under the 2026 TGA reforms.
  • Literature and Database Monitoring: Systematically searching global safety databases and medical journals for emerging safety signals.
  • Audit and Inspection Readiness: Conducting mock audits to prepare for Medical Devices Vigilance Program (MDVP) inspections.
  • CAPA Management: Establishing Corrective and Preventive Action systems to address device malfunctions.
  • Technical File Maintenance: Ensuring technical documentation remains compliant with the TGA Essential Principles.
 
DimensionLarge Service ProviderGxP Vigilance

Who manages your account?

Junior associates or offshore teams with high turnover (3–5 staff changes annually). Your account is one of 50–100 managed by that team.

Carl Bufe (Principal Consultant) – 24-year industry veteran with dual expertise in clinical pharmacy and GxP operations. You work directly with decision-makers.

Response time

Slow. Simple requests require formal Change Orders, multi-layer approvals, and 2–4 week turnarounds.

Agile & Direct. We adapt within 48 hours to new TGA requests, safety signals, or priority changes without bureaucratic delay.

System customization

You receive “global templates” designed for FDA/EMA compliance; Australian TGA nuances are retrofitted. Systems often don’t fit your therapeutic area or product risk profile.

Bespoke Build. We design your pharmacovigilance system specifically for Australian TGA expectations, your product risks, and your operational capacity.

Cost structure

High overheads (office costs, management layers, sales teams, international infrastructure). These costs flow to you.

Lean & Direct. You pay for senior expertise and results—not agency administration, overhead allocation, or geographic bloat. 30–40% cost advantage for equivalent or better service.

Accountability during inspection

“Best efforts” support. If findings occur, inspection-prep becomes a separate fee engagement. No skin in the game.

Full Accountability. We stand beside you during the inspection because we built the system. Any findings reflect on our work, so quality is non-negotiable.

Capability transfer

Systems often create dependency. You own the documentation, but staff turnover means you lose institutional knowledge.

Complete Independence. Every engagement includes documentation, training materials, templates, and structured handover. You own the system when we step back.

Therapeutic area expertise

Generalist approach; little depth in oncology, rare disease, vaccines, or device combination products.

Deep Focus Areas. Carl has specialized experience in oncology pharmacovigilance, rare disease safety, vaccine safety monitoring, and device-drug combinations.

Australian regulatory fluency

Compliance with TGA is one region among 20–30 markets. Australian nuances are secondary.

Australian-First Approach. We live in this regulatory environment; we understand TGA inspection patterns, PVIP criteria, and local healthcare context—not translating from a global playbook.

Get In Touch

Global Regulatory Experience (Establishes Authority)

TGATherapeutic Goods Administration (TGA) – Primary regulator for Australian medicines and medical devices; PVIP inspection criteria and post-approval safety requirements
MedsafeMedsafe – New Zealand medicines and medical devices safety authority; harmonised approach for ANZ sponsors
FDAU.S. Food and Drug Administration (FDA) – Centre for Drug Evaluation and Research (CDER) and Centre for Devices and Radiological Health (CDRH); pharmacovigilance and adverse event reporting requirements
EMAEuropean Medicines Agency (EMA) – Good Pharmacovigilance Practices (GVP) guidelines and post-authorization safety requirements across EU competent authorities
Integrated Global SafetyIntegrated Global Safety – Multi-regional safety strategy harmonization ensuring compliance across jurisdictions while optimizing resource efficiency

Case Studies

Three real-world examples demonstrating how we build inspection-ready pharmacovigilance capability under tight timelines and regulatory pressure.

Case Study 1

  • Client profile: Emerging Australian biopharmaceutical company preparing for first product launch; no PV infrastructure.
  • Challenge: No SOPs, oversight or case processing workflows; QPPVA nomination required within 8 weeks; team needed to be TGA-ready by launch.
  • Solution: Rapid system design, documentation, mock inspection and intensive training aligned to the approval timeline.
  • Result: On-time launch with an inspection-ready PV system. 18 months after the first global audit, the second global audit reported zero safety system findings.

Case Study 2

  • Client profile: Mid-size sponsor running multiple Australian clinical studies using a mix of CROs and internal medical oversight.
  • Challenge: SSI identification and escalation were inconsistent; decisions were tracked in email; expedited reporting to TGA lacked a controlled workflow and audit trail.
  • Solution: Designed an end-to-end SSI framework – criteria and decision tree, controlled intake and triage, medical review templates, expedited reporting workflow, and evidence-ready tracking log.
  • Result: Consistent SSI escalation across studies, improved expedited reporting timeliness, and a defensible SSI audit trail for TGA and internal QA.

Case Study 3

  • Client profile: Sponsor supported by a third-party consultant who requested specialist PV support during a high-pressure audit window.
  • Challenge: Rapid-fire audit queries, fragmented evidence sources, and limited time to pull together coherent responses on oversight, timeliness and safety decisions.
  • Solution: Set up a “war room” operating model – centralised request triage, evidence mapping, controlled response drafting, SME coaching for interviews, and a live tracker for statuses and submissions.
  • Result: Coherent, complete responses delivered within timelines, reduced internal friction, and closure of the audit period with a documented, credible improvement plan.

Common Questions and Answers

How long does it take to set up a compliant PV system from scratch?

A fully documented, audit-ready pharmacovigilance system can be built in 6–12 weeks for most sponsors, depending on portfolio complexity and existing infrastructure. This includes SOPs, QPPV nomination, case processing workflows, signal detection frameworks, and TGA reporting templates. We work alongside your team during this period to ensure knowledge transfer and system ownership from Day 1.

Can I outsource just part of my PV function, or does it need to be all-or-nothing?

You have full flexibility. Many sponsors use a hybrid model: we provide QPPV oversight and mock inspections, while your internal team handles day-to-day case processing. Others outsource specific high-risk activities like signal detection or PSUR preparation. During the initial consultation, we assess your current capacity and design a service model that fills gaps without creating dependency.

What happens if I need to transition my PV system back in-house later?

All systems we build are designed for capability transfer, not vendor lock-in. You retain full ownership of SOPs, templates, audit trails, and training materials. If you later hire an internal QPPV or expand your team, we provide a structured handover period (typically 4–8 weeks) with shadowing, documentation reviews, and transition support. Our goal is to make you independent—not permanently reliant on external consultants.

What does a Pharmacovigilance Consultant do?

A Pharmacovigilance Consultant helps pharmaceutical sponsors establish and maintain safety systems that comply with TGA regulations. This includes acting as the QPPVA, managing adverse event reporting, and preparing for regulatory inspections.

Do I legally need a QPPV in Australia?

Yes. Under the Therapeutic Goods Act, all sponsors of listed or registered medicines must have a nominated Qualified Person for Pharmacovigilance (QPPV) residing in Australia who is responsible for the safety system.

How much does a Pharmacovigilance Consultant cost compared to a CRO?

Hiring an independent consultant is often 30–40% more cost-effective than a large CRO because you avoid high overheads and “scope creep” fees. You pay for senior expertise, not junior administration.

Can you handle Medical Device vigilance as well?

Yes. We manage end-to-end device vigilance, including Manufacturer Incident Reports (MIR) and recall management, ensuring alignment with the latest ARGMD requirements.

References

  1. Therapeutic Goods Administration (TGA) – Good Clinical Practice (GCP) Inspection Program 2023-2024 (Australian Government Department of Health and Aged Care)
  2. International Council for Harmonisation (ICH) – ICH E6(R3) Guideline for Good Clinical Practice  (Final Version, Adopted 6 January 2025)
  3. National Health and Medical Research Council (NHMRC) – Australian Code for the Responsible Conduct of Research 2018  (NHMRC, Australian Research Council (ARC), Universities Australia, 2018)
  4. U.S. Food and Drug Administration (FDA) – 21 CFR Part 11 – Electronic Records; Electronic Signatures – Scope and Application (Guidance for Industry, U.S. Department of Health and Human Services, 2003)
  5. European Medicines Agency (EMA) – EU GMP Annex 11: Computerised Systems  (European Commission, Effective 30 June 2011)
  6. Society for Clinical Data Management (SCDM) – Audit Trail Review: A Key Tool to Ensure Data Integrity – Industry Position Paper  (SCDM and eClinical Forum Collaboration, Version PR1, 2021)
  7. International Society for Pharmaceutical Engineering (ISPE) – GAMP® 5 Guide: A Risk-Based Approach to Compliant GxP Computerized Systems, Second Edition (ISPE, Published August 2022)
  8. International Council for Harmonisation (ICH) – ICH E8(R1) Guideline: General Considerations for Clinical Studies (Step 5, Adopted 2 November 2021)

Disclaimer

This article is provided for educational and informational purposes only. It is intended to support general understanding of regulatory concepts and good practice and does not constitute legal, regulatory, or professional advice.

Regulatory requirements, inspection expectations, and system obligations may vary based on jurisdiction, study design, technology, and organisational context. As such, the information presented here should not be relied upon as a substitute for project-specific assessment, validation, or regulatory decision-making.

For guidance tailored to your organisation, systems, or clinical programme, we recommend speaking directly with us or engaging another suitably qualified subject matter expert (SME) to assess your specific needs and risk profile.

Revision: 2.0  (22 Jan 2026)