Responsibilities
- Working closely with the Clinical Safety Manager to ensure each project deliverables are met;
- Collect, process, and track serious adverse event (SAE) reports and clinical event documents;
- Generate and track study report safety narratives;
- Coordinate safety surveillance activities (e.g., lab review and trend analysis);
- Generate Investigator Safety Letters and distribution to health authority;
- Assist in preparation of clinical safety documents
- Perform safety submissions of expedited/periodic reports in Singapore/Taiwan
Qualifications
- Bachelor’s degree in health/life sciences with 1 year of clinical safety experience or 2 years of pharmaceutical research experience;
- Proficient in a range of Clinical Safety tasks, as detailed in the ‘responsibilities’ section (above)
- Excellent time management skills with an ability to work on tight timelines;
- An ability to interact well within a team environment, but also work independently and manage own workload;
- Proficient in Microsoft Office and demonstrated ability to efficiently use safety database;
- Strong attention to detail;
- Demonstrate comprehensive knowledge of Good Clinical Practice (GCP) guidelines
