Senior Scientist Aggregate Reporting
Job Summary
To lead aggregate reporting efforts, the full-time remote Senior Scientist Aggregate Reporting will author and manage Aggregate Safety Reports, coordinate with stakeholders for data collection, and ensure compliance with regulatory guidelines throughout the report lifecycle.
Key responsibilities
- Author and manage Aggregate Safety Reports for various health authorities, ensuring accuracy and completeness
- Coordinate with stakeholders to gather necessary data and maintain timelines for report preparation and submission
- Mentor junior team members and conduct training sessions to enhance team capabilities in aggregate reporting
Required qualifications
- Bachelor's or Master's degree in life sciences or healthcare discipline
- 5-8 years of relevant experience in aggregate reporting or drug safety
- Advanced knowledge of global regulatory requirements and drug safety guidelines
- Familiarity with safety databases such as ARGUS or ARIS G
- Experience in conducting literature reviews and signal management activities
Complete Job Description
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