Description
Responsibilities- Review study protocols, statistical analysis plans, program safety analysis plans, and other clinical study-related documents
- Review standard design of tables, figures, and listings for safety data from clinical studies
- Signal detection, evaluation, and management
- Implement signal detection strategy approved by GSO
- Review adverse event data, literature, and other Safety-relevant data for the purpose of signal detection
- Risk management and minimization (incl. post-approval commitments)
- Provide safety contents for risk management plans
- Develop or update strategy and content for regional risk management plans
- Periodic (aggregate) safety reporting
- Manage report submission schedule
- Author or provide content for periodic safety reports; e.g., development safety update report (DSUR), periodic update safety report (PSUR) / periodic benefit risk evaluation report (PBRER)
- Activities related to new drug applications and other regulatory filings
- Provide safety contents for filings
- Compliance
- Contribute to implementation of Corrective Action and Preventive Action (CAPA) for assigned products
- Partnerships and integration activities
- Obtain non-ICSR safety information from licensing partners for periodic safety reports
- Review safety documents prepared by licensing partners
- Quality control
- Perform quality control checks for deliverables of the Global Safety Team
Requirements
- 4+ years Drug safety experience in a biotech/pharmaceutical setting
- Clinical/medical research experience
- Processes and regulations for pharmacovigilance and risk management
- Drug development and lifecycle management
- Safety data capture in clinical development and post-market settings
- Safety database structure and conventions
- MedDRA and other dictionaries used in pharmacovigilance
- Methods of qualitative and quantitative safety data analysis
- Product and disease state knowledge
- General medicine, epidemiology, physiology, and pharmacology
- Signal detection and evaluation
- Aggregate data analysis
- Good clinical and scientific judgment
- Application of medical concepts and terminology
- Document writing and source document review
- Data interpretation and synthesis
- Basic skills in application of statistical and epidemiological methods to pharmacovigilance
- Ability to convey complex, scientific data in an understandable way