APS6 Pharmacovigilance Evaluation / Compliance Officer
Recruiter Name : Australian Government Therapeutic Goods Administration - Symonston ACT
Vacancy Details
Salary : $81,784 - $92,265 a year
Job Location : Symonston, ACT
The Pharmacovigilance and Special Access Branch is responsible for undertaking post-market monitoring of medicines and vaccines to ensure that they continue to maintain an appropriate level of quality, safety and efficacy following entry into the Australian marketplace.
We are seeking staff to fill three positions working across the following functions:
• the Pharmacovigilance Inspection Program which assesses sponsors’ compliance with their pharmacovigilance obligations and identifies areas for improvement in their pharmacovigilance systems.
• Risk Management Plan Evaluation, which involves evaluating, negotiating and monitoring compliance with risk management plans to ensure that the risks of selected prescription medicines and biologicals are adequately monitored and mitigated.
• Periodic Safety Update Report evaluation, which involves evaluating reports produced by sponsors to inform ongoing monitoring of the benefit–risk balance of medicines as new information emerges.
We are seeking staff to fill three positions working across the following functions:
• the Pharmacovigilance Inspection Program which assesses sponsors’ compliance with their pharmacovigilance obligations and identifies areas for improvement in their pharmacovigilance systems.
• Risk Management Plan Evaluation, which involves evaluating, negotiating and monitoring compliance with risk management plans to ensure that the risks of selected prescription medicines and biologicals are adequately monitored and mitigated.
• Periodic Safety Update Report evaluation, which involves evaluating reports produced by sponsors to inform ongoing monitoring of the benefit–risk balance of medicines as new information emerges.
How to apply:
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