Pharmacovigilance Officer

Responsibilities

• Process Individual Case Safety Reports (ICSR) from post-marketing and clinical trial sources in compliance with regulations and client requirements
• Manage SAE/SUSAR independently, including submissions, unblinding, and clinical trial reconciliations
• Prepare database outputs for periodic reporting such as PBRER, DSUR, and PADER
• Mentor and train junior employees and assist in procedure optimization

Requirements

• Degree in Life Sciences, Biomedical sciences, or related healthcare field (Chemistry, Biology, Biotechnology, Veterinary Science, etc.)
• Demonstrated experience in Pharmacovigilance case processing
• Strong time management, organization, and multitasking skills
• Advanced English proficiency (C1 level or higher)
• Strong interpersonal and communication skills

About the Company

PrimeVigilance is a global pharmacovigilance specialist helping clients navigate complex regulations while keeping patient safety at the center of every decision, from early development through to post-marketing surveillance.