Pharmacovigilance in Australia is regulated by the Therapeutic Goods Administration (TGA). Medicine sponsors must collect adverse reactions from every source and report serious Australian adverse reactions to the TGA within 15 calendar days, significant safety issues within 72 hours and other safety issues within 30 days. New medicines and new uses carry a Black Triangle to encourage reporting, and suspected adverse events are published in the TGA’s Database of Adverse Event Notifications (DAEN).
Key takeaways
- Regulator: the Therapeutic Goods Administration (TGA).
- Serious Australian adverse reactions: report within 15 calendar days.
- Significant safety issues: within 72 hours; other safety issues: within 30 days.
- The Black Triangle marks new medicines and new uses — it is not a safety warning.
- Indian PV teams also process cases for Australian sponsors; moving to Australia needs a work visa.
On this page ⌄
Pharmacovigilance in Australia and the TGA
Pharmacovigilance is the work of finding, checking and preventing side effects of medicines. In Australia, the Therapeutic Goods Administration (TGA) oversees this work. The TGA is part of the national Department of Health.
Every medicine sold in Australia is listed on the Australian Register of Therapeutic Goods (ARTG). The firm that owns each listing is called the sponsor. The sponsor must run a drug-safety system for that medicine.
What medicine sponsors must do
- Collect Australian adverse reactions from all sources — patients, health professionals, staff, literature, social media and post-registration studies
- Report serious reactions and significant safety issues to the TGA on time
- Watch for changes to the medicine’s benefit–risk balance and act promptly
- Update the Product Information (PI) and Consumer Medicine Information with new safety information
- Nominate a person in Australia as the main pharmacovigilance contact for the TGA
Reporting timelines for pharmacovigilance in Australia
Deadline
- Serious Australian adverse reactions (expected or unexpected, including Australian literature cases)
- Within 15 calendar days of first receipt
- Significant safety issues
- Within 72 hours
- Other safety issues
- Within 30 calendar days
A valid report needs four things: a reporter, a patient, a suspect medicine and a suspected reaction. These are the same four basics taught in every PV course.
The Black Triangle Scheme and the DAEN database
Black Triangle Scheme
Since 2018, new medicines carry a black triangle on their leaflets. So do older medicines with a new use. It asks people to report side effects. It does not mean there is a known problem.
DAEN
This is the TGA’s public database of side-effect reports, going back to 1971. You can search it by medicine, age, sex and MedDRA term. Each entry is a suspicion, not proof.
Safety issues found through Australian reporting
Australian reports have helped spot important safety issues. Examples listed in Australian Prescriber (2018) include:
Adverse event
- Risperidone
- Cerebrovascular events in patients with dementia
- Methotrexate
- Hepatitis B reactivation
- Pregabalin
- Suicidal thoughts
- Zolpidem
- Next-day impairment
- Rotavirus vaccine
- Intussusception
- Denosumab
- Severe low calcium (hypocalcaemia)
- Proton pump inhibitors
- Acute interstitial nephritis
- Exenatide
- Pancreatitis
Careers in pharmacovigilance in Australia
Common roles include Drug Safety Associate, case processor, Drug Safety Scientist, report and signal specialist, and PV quality roles. Many global firms handle Australian cases from teams in India. So you can work on Australian cases without moving. Working in Australia itself needs a visa. That depends on the employer and the law. BCRI does not promise jobs abroad.
See how roles grow in our pharmacovigilance career path, and compare the rules in pharmacovigilance in USA and Canada.
Duration
- Pharmacovigilance Training
- 2 months
- PV Database Training (Clinevo)
- 20 hours
- Online PG Diploma (US, UK, AU)
- 5.5–7.5 months
Fee
- Pharmacovigilance Training
- ₹22,500
- Online PG Diploma (US, UK, AU)
- See page
Best for
- Pharmacovigilance Training
- ICH E2 and major regulators’ rules, case processing on a safety database
- PV Database Training (Clinevo)
- Hands-on safety-database skills
- Online PG Diploma (US, UK, AU)
- Learners living in Australia and other countries
FAQs
Who regulates pharmacovigilance in Australia?
The Therapeutic Goods Administration (TGA), part of the Australian Government Department of Health.
How fast must serious adverse reactions be reported in Australia?
Sponsors must report serious Australian adverse reactions to the TGA within 15 calendar days of first receipt. Significant safety issues must be reported within 72 hours.
What is the Black Triangle Scheme?
Since 2018, new medicines and medicines approved for new uses carry a black triangle on their product information to encourage adverse-event reporting. It is not a safety warning.
What is the DAEN?
The TGA’s public Database of Adverse Event Notifications, listing suspected adverse events reported since 1971. Reports are suspicions, not proof that the medicine caused the event.
Can I study pharmacovigilance online from Australia?
Yes. BCRI’s live online classes are open to learners abroad, with batch times confirmed for your time zone and recordings for 3 months.