Drug Safety Physician
- Lead medical safety assessment of individual case safety reports
- Oversee appropriate review of all safety data from various sources (e.g., pre-clinical studies, clinical trial data, post-marketing data, and published literature) throughout the development process for assigned products
- Conduct safety signal detection activities, including monitoring, evaluation, interpretation, and appropriate management and communication of safety information to the Safety Management
- Team (SMT) for assigned products
- Manage ongoing and cross-functional assessment of the benefit–risk profile and related actions, including writing and updating benefit–risk documents for assigned marketed products and development compounds
- Provide expert safety review input into all critical documents for clinical development of products, including:
- Protocols and amendments
- Informed Consent Forms (ICFs)
- Investigator’s Brochures (IBs)
- Clinical Study Reports (CSRs)
- Investigational New Drug (IND) applications
- Clinical Trial Applications (CTAs)
- Collaborate with the VP, DS to develop strategy and implementation plans for safety and benefit–risk management for assigned products
- Write and/or review key content for safety evaluation documents of assigned products.
- Lead the implementation of Risk Management Plans (RMPs) and evaluation of the effectiveness of Risk Minimization Measures (RMMs).
- Write and/or review periodic safety reports for assigned products, such as:
- Periodic Benefit–Risk Evaluation Reports (PBRERs)
- Development Safety Update Reports (DSURs)
- Assist in the development and maintenance of relevant policies, Standard Operating Procedures (SOPs), and work instructions
- Support inspection of readiness activities to ensure compliance with global regulatory standards
- Doctor of Medicine (M.D.) degree required
- Minimum of 8–10 years of experience in pharmacovigilance (PV), including medical review, aggregate safety reporting, safety evaluation, and risk management
- Advanced knowledge of global pharmacovigilance regulatory requirements, including regions such as the United States (US), European Union (EU), Latin America (LATAM), and the Asia Pacific (APAC) region
- Experience in clinical research and drug development preferred
- Strong competency in understanding the scientific background of disease mechanisms and medical therapies
- Demonstrated ability to analyze and present complex safety data clearly and effectively
- Experience in clinical research or pharmacoepidemiology preferred
- Proven experience leading cross-functional safety teams
- Excellent communication, leadership, and organizational skills
- Demonstrated ability to think strategically and convey complex issues clearly to diverse audiences
- Strong understanding of the Medical Dictionary for Regulatory Activities (MedDRA) terminology and its application
- Proficiency in Microsoft Office (Word, Excel, and PowerPoint)
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