Drug Safety Scientist

The Fountain Group is recruiting for a confidential client. The Drug Safety Scientist processes and quality-checks clinical trial and post-market individual case safety reports, supports regulatory reporting, and resolves safety database reconciliation issues.

Responsibilities

• Responsible for case processing and/or QC of clinical trial ICSRs and post-market case processing from sanctioned countries
• 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

Company

• Staffing firm providing contingent workforce solutions
• Tampa, Florida, USA
• https://thefountaingroup.com/
• Founded in 2001
• 501-1000 employees

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
• Staffing firm providing contingent workforce solutions.
• Tampa, Florida, USA
• https://thefountaingroup.com/
• H1B Sponsorship
• Data Powered by
• Distribution of Different Job Fields Receiving Sponsorship
• Represents job field similar to this job
• Engineering and Development
• Management and Executive
• Legal and Compliance
• Marketing
• Customer Service and Support
• Accounting and Finance
• Trends of Total Sponsorships
• *2026
• (41)
• 2025
• (43)
• 2024
• (31)
• 2023
• (21)
• 2022
• (42)
• 2021
• 2020
• (14)
• Late Stage
• Leadership Team
• Jahnavi Patel
• Finance Business Partner

Required skills

• Pharmacovigilance, ICSR Processing, FDA, ICH, and EU Pharmacovigilance Regulations, ArisG, Argus, Veeva, Medical Terminology, Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Outlook

Preferred skills

• Written and Verbal Communication

Experience

• 4+ years