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

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Drug Safety Officer