Safety Specialist II (Pharma)

TL;DR

Safety Specialist II (Pharma): Processing and reporting individual case safety reports (ICSR) for clinical trials and post-marketing safety programs with an accent on data accuracy and regulatory compliance. Focus on triaging cases, coding events using MedDRA/WHODrug, and maintaining the Argus Safety Database.

Location: Remote (Serbia)

Company

hirify.global is a professional services provider specializing in clinical trial and pharmacovigilance safety programs.

What you will do

• Process and triage ICSRs according to SOPs and project-specific safety plans.
• Enter and manage safety data within the Oracle Argus Safety Database.
• Code medical events, history, and concomitant medications using MedDRA and WHODrug.
• Draft detailed case narratives and resolve information queries.
• Coordinate safety data reconciliation between clinical and safety databases.
• Ensure the timely distribution of expedited reports and maintain the Trial Master File (TMF).

Requirements

• Minimum 2 years of experience in clinical trial drug safety within the Pharma or CRO industry.
• Bachelor’s degree in Pharmacy, Nursing, Life Sciences, or a related health field.
• Hands-on experience with the Oracle Argus Safety Database.
• Working knowledge of MedDRA and WHODrug coding dictionaries.
• Proficiency in FDA, EMA, MHRA, and ICH global safety regulations.

Culture & Benefits

• Equal Opportunity Employer providing a diverse and inclusive work environment.
• Remote work arrangement based in Serbia.
• Professional growth within a specialized safety team.