Safety Specialist II

Key Responsibilities:

• Process ICSRs according to SOPs and project-specific safety plans.
• Triage, evaluate, and enter data into Argus Safety Database.
• Draft narratives and coordinate with data management for reconciliation.

Qualifications:

• Minimum 2 years of clinical trial drug safety experience.
• Bachelor’s degree in Pharmacy, Nursing, or related life science field.
• Working knowledge of MedDRA, WHODrug, and global safety regulations.

About the Role:

• Participate in audits and inspections as required.
• Maintain understanding of SOPs, GCP, ICH, and FDA regulations.
• Attend department meetings and project teleconferences.