Senior Drug Safety Specialist

A company is looking for a Senior Drug Safety Specialist to manage drug safety activities and ensure compliance with regulations.

Key Responsibilities

Manage safety issues for clinical studies and direct team efforts for safety review committees

Triage and process Individual Case Safety Reports (ICSRs) and Serious Adverse Events (SAEs) for regulatory submission

Mentor Pharmacovigilance staff and ensure data integrity and compliance with regulations

Required Qualifications

RN, Pharmacist, or a BS / BA in Health Sciences with 5+ years of drug safety or pharmacovigilance experience

Experience with Post-Marketing and Clinical case processing

Proficiency in medical terminology and safety database experience preferred

Medical writing experience with PSURs, DSURs, and SDEAs preferred

Expert knowledge of global GCPs and pharmacovigilance requirements