Drug Safety Associate - ICSR

Roles & Responsibilities
• Approve and schedule Individual Case Safety Reports (ICSRs) in the Argus database for submission to Health Authorities
• Submit safety cases to Health Authorities, Business Partners, and Affiliates as per regulatory requirements
• Ensure strict adherence to internal and external timelines to maintain regulatory compliance
• Schedule and approve regulatory reports based on defined reporting obligations
• Perform quality review of ICSRs to ensure accuracy, completeness, and compliance with PV guidelines
• Support regulatory submission activities and maintain high-quality pharmacovigilance standards

Qualification
• B.Pharm (Bachelor of Pharmacy) / M.Pharm (Master of Pharmacy)

Experience
• 4 to 6 years of relevant Pharmacovigilance experience
• Mandatory hands-on experience in ICSR Quality Review and Regulatory Submissions
• Strong working experience with the Argus Safety Database

Skills
• Strong knowledge of global Pharmacovigilance regulations and reporting guidelines
• Expertise in ICSR quality review, compliance, and regulatory submissions
• High attention to detail with strong analytical skills
• Excellent communication, coordination, and time management abilities

About the Company
Vizen Life Sciences is a growing life sciences organization focused on delivering high-quality pharmacovigilance, regulatory, and safety solutions, supporting global healthcare and regulatory compliance standards.