Spectrum Pharmaceuticals, a biotechnology company with a primary focus in oncology and hematology. The Company also has a diversified pipeline of novel drug candidates. The Company’s strategy is comprised of acquiring, developing and commercializing a broad and diverse pipeline of late-stage clinical and commercial drug products. The Company has aggressive business development and commercial operation teams that support a robust drug development program encompassing clinical development, medical research, regulatory affairs, biostatistics and data management. The Company also leverages the expertise of its worldwide partners to assist in the execution of its strategy.
Post : Drug Safety/Pharmacovigilance Specialist
RESPONSIBILITIES:
• Receives safety related information from all sources, including clinical trial cases, spontaneous reports, and literature reports (U.S. and global)
• Performs triage for incoming cases, considering assessments of seriousness, listedness, and causality
• Performs accurate data entry into the safety database
• Conducts MedDRA coding
• Prepares high quality case narratives, including identifying relevant information from source documents
• Produces accurate safety reports (i.e. CIOMS/MedWatch Forms) for submission to regulatory authorities and partners
• Tracks due dates for partner submissions
• Conducts reconciliation activities with partners
• Conducts peer review of cases in the safety database for quality control
• Produces queries as needed for clarification of clinical reports
• Conducts active follow-up, including written and verbal follow-up
• Conducts reconciliation of the safety and clinical databases for serious adverse events
• Supports the management of case processing deadlines
• Extracts data from the safety database, as needed
• Compiles safety information for aggregate safety reports and other safety related reports
• Conducts departmental specific projects as needed
Candidate Profile
• A degree in a healthcare discipline is preferred (e.g. pharmacist, nurse)
• Minimum of one year of safety experience in a pharmaceutical company
• Understands local and applicable foreign safety regulations
• Strong clinical background, with ability to interpret medical records (e.g. laboratory results, medical conditions)
• Experience with use of safety databases, preferably Argus Safety Database
• Strong written communication skills, with ability to write clearly and concisely
• Attention to detail and the ability to prioritize
• Time management skills with ability to prioritize to meet required deadlines
• Ability to collaborate with team members
Additional Information
Experience : 1 years
Location : Irvine, California
Industry Type : Pharma
Functional Area : Drug Safety/Pharmacovigilance
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