Preferred Location
- Remote with occasional travel to site for meetings in Los Angeles County, CA
Job Summary
The Drug Safety Officer (DSO) at Angitia Biopharmaceutical is responsible for the overall safety profile, risk management, benefit-risk assessment, and signal detection of the assigned product(s). In this role, you will participate, interface, and be an integral part of the global team in the clinical development and risk management activities of products from the preclinical phase to Phase 3.
Key responsibilities include:
Product safety profile, benefit-risk evaluation, risk management
- Be responsible for the overall safety profile of the assigned product(s)
- Develop core safety strategy, lead the benefit-risk discussions with internal and external stakeholders, including but not limited to regulatory authorities
- Lead the development and maintenance of the risk management plan
- Lead the Benefit-Risk Team (BRT) and participate in the Executive Safety Committee (ESC) as appropriate
- Ensure compliance with global regulations and ICH guidelines regarding the preparation and submission of required regulatory expedited and periodic reports
- Author or provide content for periodic safety reports; e.g., development safety update report (DSUR), other aggregated safety reports per health authority or Institutional Review Board/ethical committee requirements
Clinical trial safety
- Review and provide safety input for Investigators' Brochure, study protocols, Informed consent form, regulatory documents, statistical analysis plans, clinical study report, and other clinical study-related documents as needed
- Provide safety support for activities related to Safety Review Committee (SRC) or Data Monitoring Committees (DMCs) and internal data review team meeting
- Review and perform a medical assessment of safety data from clinical studies
- Oversee Clinical Research Organization activities, including but not limited to clinical trial safety data collection and submission and contract review
Signal detection, evaluation, and management
- Be responsible for leading, reviewing, and performing the safety signal detection and assessment for the assigned product(s)
- Implement signal detection strategy for the assigned product(s)
- Perform quantitative and qualitative analyses and author safety assessment report to evaluate safety signals
Desired Knowledge And Skills
Drug safety knowledge
- Safety data capture and safety database utility in clinical development settings
- Signal detection and evaluation
- Basic skills in the application of statistical and epidemiological methods to pharmacovigilance
- Aggregate data analysis and interpretation
- Safety risk monitoring, management, and minimization
- Product and disease state knowledge
- General medicine, epidemiology, physiology, and pharmacology
- Document writing and source data review
Other Skills
- Ability to collaborate in cross-functional team settings
- Organizational and time management skills
- Critical scientific assessment and problem-solving
- Oral presentation skills
- Written communications, including medical/scientific writing
Education & Qualification
- MD with 2+ years of safety/PV experience, Pharm D., or Ph.D., or RN with 4 years of safety/PV experience
- Clinical experience in either an accredited academic setting or private practice setting OR
- Drug safety in the biopharmaceutical industry or regulatory agency
Salary range：$175k to $250k