Global Safety Reporting Officer

13 hours ago


Sydney, New South Wales, Australia Southern Star Research Full time
About the Company

Southern Star Research is a leading Australian full-service Contract Research Organisation (CRO) headquartered in Sydney, Australia. We specialise in providing clinical research services to clients across the pharmaceutical, medical device, and biotechnology markets in Australia, New Zealand, and the Asia Pacific region.

We value attracting and retaining excellent staff as key to developing a high-quality CRO and providing our customers with the best service possible. Our culture is focused on fostering and maintaining a positive, professional, and productive work environment.

Job Requirements

The successful candidate will possess:

  • Minimum 2 years' experience working in safety/pharmacovigilance/regulatory within a pharmaceutical company or CRO focused on clinical trials.
  • Experience using Safety/PV database platforms, preferably Oracle Agrus Safety.
  • Strong understanding of APAC safety operations from a regulatory perspective, including regulatory safety reporting timelines.
  • Ability to analyse safety information (SAE/SADE initial and follow up reports), identify and raise queries.
  • Excellent interpersonal and communication skills, including proficiency in medical terminology.
  • Appropriate tertiary qualifications in the medical, pharmaceutical, or healthcare disciplines.
Benefits

We offer a range of benefits, including:

  • An attractive remuneration package.
  • Genuine work-life balance.
  • Career stability and security.


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