Drug Safety Specialist required for our growing CRO business. Great opportunity in a business with a supportive, inclusive culture.

24th September, 2026

Drug Safety Specialist

Who are we? We’re Avance Clinical a Contract Research Organisation. We offer specialised services supporting drug development for the pharmaceutical and biotechnology industry. Those in our industry know we’re experts in our field. We’ve won numerous industry accolades & have completed over 500 studies over the last 5 years. We’ve grown every year since 2019 & have doubled in size over the last 2 years… we’ve a positive future ahead of us.

Why should you join Avance Clinical? We appreciate that our most important asset is our people. We offer a fun, friendlywork workplace and a culture that values honesty and respect. We have a strong sense of team. We genuinely appreciate each individual but recognise the collective when achieving success.

The role This role is responsible for the provision of Drug Safety reporting and management services for assigned projects, ensuring the preparation (or review) of Safety Reporting Plans (SRP), the collection, processing and reporting of safety events and other safety information in accordance with the Clinical Study Protocol (CSP), Avance (or sponsor) Standard Operating Procedures (SOPs), ICH GCP guidelines and other applicable regulatory requirements.

Core Responsibilities Include

- Ensure receipt, assessment (initial and follow up), processing and tracking of safety-related events (SAEs, EIU reports or Events of Special Interest) from study sites in accordance with the CSP, applicable regulations, SOPs,



study specific SRP and any other specific agreements related to the management of safety information for a clinical trial.
- Generate concise and accurate case narratives liaising with the study Medical Monitor and Sponsor Medical Representative(s) as required, in accordance with each study specific SRP and Client/Avance Clinical contractual arrangements.
- Create, modify and/or review study specific SRPs as required per project in accordance with the CSP and Client/Avance Clinical contractual arrangements.
- Participate in Study “Kick-Off” meetings with study project staff as required.
- Autonomously act as Lead Safety Officer and maintain oversight on regulatory compliance and status of safety-related services for assigned projects.
- Ensure timely reporting, tracking, filing and distribution

24th September, 2026

Drug Safety Specialist

Who are we? We’re Avance Clinical a Contract Research Organisation. We offer specialised services supporting drug development for the pharmaceutical and biotechnology industry. Those in our industry know we’re experts in our field. We’ve won numerous industry accolades & have completed over 500 studies over the last 5 years. We’ve grown every year since 2019 & have doubled in size over the last 2 years… we’ve a positive future ahead of us.

Why should you join Avance Clinical? We appreciate that our most important asset is our people. We offer a fun,



friendlywork environment and a culture that values honesty and respect. We have a strong sense of team. We genuinely appreciate each individual but recognise the collective when achieving success.

The role This role is responsible for the provision of Drug Safety reporting and management services for assigned projects, ensuring the preparation (or review) of Safety Reporting Plans (SRP), the collection, processing and reporting of safety events and other safety information in accordance with the Clinical Study Protocol (CSP), Avance (or sponsor) Standard Operating Procedures (SOPs), ICH GCP guidelines and other applicable regulatory requirements.

Core Responsibilities Include

- Ensure receipt, assessment (initial and follow up), processing and tracking of safety-related events (SAEs, EIU reports or Events of Special Interest) from study sites in accordance with the CSP, applicable regulations, SOPs, study specific SRP and any other specific agreements related to the management of safety information for a clinical trial.
- Generate concise and accurate case narratives liaising with the study Medical Monitor and Sponsor Medical Representative(s) as required, in accordance with each study specific SRP and Client/Avance Clinical contractual arrangements.
- Create, modify and/or review study specific SRPs as required per project in accordance with the CSP and Client/Avance Clinical contractual arrangements.
- Participate in Study “Kick-Off” meetings with study project staff as required.
- Autonomously act as Lead Safety Officer and maintain oversight on regulatory compliance and status of safety-related services for assigned projects.
- Ensure timely reporting,

📌 Drug Safety Specialist (Melbourne)
🏢 Avance Clinical Pty
📍 Melbourne