Drug Safety Scientist
Company: The Fountain Group Agency
- Location: Illinois, United States
- Work mode: Remote
- Seniority: Senior
- Employment type: Contract
- Posted: 13 days ago
- Offer language: English
Job description
Pay: $60.23/Hour
Duration:1 year
Location: Remote (Preferred EST)
Job Scope:
- Responsible for case processing and/or QC of clinical trial ICSRs and post-market case processing from sanctioned countries.
Key Responsibilities:
- Triage, Intake, case entry and QC of ICSRs originating from Biogen sponsored studies or other assigned cases
- Includes narrative writing, MedDRA coding, drafting of follow-up queries and event notifications to internal stakeholders
- Perform retrospective quality checks on processed cases
- Independently manage assigned cases, accounting for weekends and holidays, to deliver cases to internal stakeholders on time and ensure case completion allowing for on-time regulatory reporting
- Review and resolution of reconciliation issues between the clinical and safety databases per in collaboration with Data Management
- Provide investigation details into late regulatory reporting of CT cases
Qualifications:
- Knowledge of Global and local safety regulations
- Excellent written and verbal communication skills
- Experience in ICSR processing in safety database systems such as ArisG, Argus and Veeva
- Understanding of global safety reporting regulations and guidelines including the FDA, ICH, and EU Regulations and Requirements for Pharmacovigilance
- Strong computer skills within Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook)
- Knowledge of medical and clinical practices and a strong understanding of medical concepts and terminology required
- Bachelor’s degree in science or healthcare related field
- 4+ years of experience in pharmacovigilance
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