Remote Drug Safety Scientist – Pharmacovigilance Expert

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

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,