Southern Star Research is a full-service Contract Research Organization (CRO) dedicated to navigating the complexities of bringing new medical products to market. With a legacy of excellence that began 14 years ago in Sydney, we have grown from a small, passionate team into a global network of experts committed to delivering high-quality services in medical writing, clinical monitoring, project management, biostatistics, data management, safety and medical monitoring, and quality assurance.
Southern Star Research has been recognised for its outstanding contributions to the field, winning prestigious awards such as the Frost and Sullivan 2024 Asia-Pacific Competitive Strategy Leadership Award and being named as a Great Place to Work in Australia in 2024 and 2025. Our international team continues to deliver innovative clinical trial solutions across diverse therapeutic areas, ensuring the success of every study we manage.
Due to continued growth and a strong project pipeline, we're looking for a Safety Officer (Part Time 3 days per week) to join our team in Australia.
The role
We are seeking a Safety Officer (part-time, approximately three days per week) to join our growing team and support pharmacovigilance and safety activities across Southern Star Research's clinical trials.
This role will support the safety function in ensuring safety information is captured, reviewed, and reported in accordance with regulatory requirements, study protocols and company procedures. Working within a small and collaborative safety team, the successful candidate will contribute to safety reporting, documentation, and regulatory compliance across multiple clinical studies.
Our head office is located in North Sydney, however this role offers the flexibility to be based anywhere in Australia with remote working arrangements available.
Reporting to the Chief Operating Officer, you will be responsible for
* Ensuring safety information including serious adverse events (SAEs) and serious adverse device effects (SADEs) are appropriately documented and reported in accordance with regulatory requirements and internal procedures.
* Acting as a key point of contact for investigators, site personnel and internal teams to resolve safety queries and obtain missing safety information.
* Supporting the preparation and review of safety documentation, including safety reporting plans, safety management plans and related clinical trial safety documents.
* Tracking and maintaining safety data within relevant safety databases and clinical systems, ensuring accuracy and completeness.
* Supporting compliance with applicable regulatory requirements and guidelines, including ICH-GCP and relevant regulatory authority reporting timelines.
To be successful in the role, we're looking for candidates with:
* Appropriate tertiary qualifications in a medical, pharmaceutical, scientific or healthcare discipline (pharmacy background preferred).
* 3–5 years of experience in pharmacovigilance, drug safety or clinical trial safety, ideally within a CRO environment.
* Experience supporting clinical trial safety reporting, including SAE processing and safety documentation.
* Familiarity with safety and clinical systems such as Argus Safety Database and/or Veeva systems.
* Knowledge of regulatory safety reporting requirements across jurisdictions such as TGA, FDA and EMA.
* Strong attention to detail and organisational skills, with the ability to manage safety timelines across multiple studies.
* A collaborative working style with the ability to work independently within a small team environment.
* • Excellent written and verbal communication skills, with the ability to engage effectively with investigators, sponsors and internal teams.
Why Southern Star?
* Join a passionate team committed to our shared purpose to create brighter futures, one study at a time.
* Competitive remuneration.
* Flexible work environment, with hybrid and fully remote options.
* STAR Day – one extra day off per year for you to recharge.
Diversity, Equity and Inclusion
At Southern Star Research, we are committed to fostering a safe, inclusive, and respectful workplace where everyone feels valued and empowered to contribute. We celebrate the diversity of our team and recognise the strength that comes from different perspectives, backgrounds, and lived experiences.
We are dedicated to ensuring an inclusive recruitment process and providing equal opportunities for all applicants, regardless of race, ethnicity, gender identity, sexual orientation, age, disability, or cultural background.
Role Type
Company Overview
Southern Star Research is trusted CRO offering world-class, high quality full-service clinical trails across the Asia Pacific region.
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