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Drug Safety Scientist

Virtual Vocations Inc

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

Vacancy posted 2 days ago
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