Associate Director, Safety Data Sciences
Irvine, CA, United States
USD 126K-190K (estimate) Mid-level Full Time
Tasks
- Analyze safety databases
- Apply medical judgment to benefit risk
- Assess safety signals
- Author clinical safety reports
- Communicate safety findings to leadership
- Conduct pharmacovigilance surveillance
- Evaluate signals and regulatory needs
- Maintain safety sections of regulatory documents
- Mentor and train safety scientists
- Prepare aggregate safety reports
- Prepare written signal management summaries
- Review safety data from clinical trials
- Summarize key safety data for meetings
- Support risk minimization activities
Perks/Benefits
- 401k
- Dental insurance
- Health insurance
- Long-term incentive program
- Paid Holidays
- Paid sick leave
- Paid time off
- Vision insurance
Skills/Tech-stack
Benefit-risk assessment | Clinical Summary of Safety | Clinical study | Clinical study reports | Clinical trial | Clinical trial safety | Company Core Data Sheets | Data sheets | Drug development | Medical judgment | Medical writing | Microsoft Excel | Microsoft Word | Pharmacovigilance | Project Management | Regulatory safety | Regulatory safety reporting | Risk Assessment | Risk Management | Risk Management Plan | Safety reporting | Signal Detection | Signal evaluation | Study Reports | Trial Safety
Education
Bachelor of Science | Doctor of Pharmacy | Master of Science | PhD
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