Drug Safety Scientist

The Fountain Group; Chicago (IL); Hybrid; USD 76,000 - 96,000; Full time

Job summary

The Fountain Group is seeking a pharmacovigilance specialist to handle ICSDR case processing and QC for clinical trials and post-market events. You will perform narrative writing, MedDRA coding, and draft follow-up queries to stakeholders, ensuring timely regulatory submissions from Biogen studies and other assignments.

Ideal candidates bring 4+ years in pharmacovigilance, strong regulatory knowledge (FDA/ICH/EU), and hands-on experience with safety databases such as ArisG, Argus, and Veeva,

Qualifications

• Experience in ICSR processing in safety database systems such as ArisG, Argus and Veeva.
• Knowledge of global and local safety regulations and guidelines.
• Bachelor’s degree in science or healthcare related field and 4+ years in pharmacovigilance.

Responsibilities

• Triage, intake, case entry and QC of ICSDRs from Biogen studies or other cases.
• Includes narrative writing, MedDRA coding, drafting follow-ups and event notifications.
• Perform retrospective quality checks on processed cases.
• Independently manage assigned cases to ensure on-time regulatory reporting.
• Review reconciliation issues between clinical and safety databases with Data Management.
• Provide investigation details into late regulatory reporting of cases.

Skills

Excellent written and verbal comms

Regulatory knowledge (FDA, ICH, EU)

Education

Bachelor’s degree in science or healthcare related field

Tools

ArisG

Argus

Veeva

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 ICSDRs and post-market case processing from sanctioned countries.

Key Responsibilities

• Triage, Intake, case entry and QC of ICSDRs 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