Drug Safety Scientist
Job Summary
Independently managing assigned cases, the remote Drug Safety Scientist will be responsible for case processing and quality control of clinical trial ICSRs and post-market cases, ensuring timely delivery for regulatory reporting.
Key responsibilities:
- Triage, intake, case entry, and quality control of ICSRs from Biogen-sponsored studies or other assigned cases
- Perform narrative writing, MedDRA coding, and draft follow-up queries and event notifications for internal stakeholders
- Review and resolve reconciliation issues between clinical and safety databases in collaboration with Data Management
Required qualifications:
- Bachelor's degree in science or a healthcare-related field
- 4+ years of experience in pharmacovigilance
- Knowledge of global and local safety regulations, including FDA, ICH, and EU guidelines
- Experience in ICSR processing using safety database systems such as ArisG, Argus, and Veeva
- Strong understanding of medical concepts and terminology
Complete Job Description
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