Drug Safety Specialist

Role & Responsibilities
• Handle and process adverse event and serious adverse event reports from clinical trials and post-marketing sources
• Determine appropriate action plans for incoming safety calls and reports
• Collect, process, track, and document safety cases accurately
• Prepare detailed safety narratives and reports
• Maintain safety databases and track case follow-ups
• Collaborate with internal teams and clinical research sites to ensure safety compliance
• Support regulatory compliance and safety reporting activities
• Maintain accurate safety documentation and timelines

Qualifications & Experience
• Bachelor’s degree in Nursing, Pharmacy, Pharmacology, or Healthcare-related discipline
• Clinical experience or Pharmacovigilance / Clinical Research experience preferred
• Proficient English communication skills
• Strong knowledge of medical terminology
• Proficiency in Microsoft Office tools

Skills
• Pharmacovigilance case processing
• Adverse event reporting and safety documentation
• Safety database management
• Medical terminology and narrative writing
• Regulatory compliance and GCP understanding
• Attention to detail and time management
• Strong communication and coordination skills

About the Company
• Medpace is a global Contract Research Organization (CRO) providing Phase I–IV clinical development services to biotechnology, pharmaceutical, and medical device industries across 40+ countries