Safety Science Coordinator I

Role & Responsibilities
• Assist in processing expedited and periodic safety reports
• Manage AE and SAE case flow including logging, triaging, and routing
• Enter and maintain safety data in adverse event tracking systems
• Draft patient safety narratives and perform MedDRA coding where applicable
• Conduct listedness assessments for marketed products
• Submit expedited safety reports to regulatory authorities, ethics committees, investigators, clients, and vendors
• Ensure safety submissions meet study-specific and regulatory timelines
• Maintain adverse event trackers, project documentation, and study files
• Support quality review activities and database reconciliation
• Work in compliance with SOPs and Quality Management Systems
• Schedule meetings and provide administrative support to safety teams
• Support mentoring of junior safety assistants and build cross-functional collaboration

Qualification
• Degree in Pharmacy, Life Sciences, Biological Sciences, Nursing, Medical Sciences, or related disciplines
• Acceptable qualifications include B.Pharm, M.Pharm, Pharm.D, MSc, BSc, BDS, or Nursing

Experience
• 0–1 year of experience in pharmacovigilance, drug safety, or clinical research operations
• Freshers with relevant academic exposure are eligible
• Exposure to AE/SAE processing, narrative writing, or safety databases preferred

Skills
• Strong attention to detail and data accuracy
• Good written and verbal communication skills
• Ability to manage multiple priorities and meet timelines
• Logical, numerical, and analytical reasoning skills
• Proficiency in MS Office and safety database tools
• Strong teamwork and cross-functional collaboration abilities

About the Company
• Fortrea is a global organization specializing in clinical development and safety operations
• Supports pharmaceutical and biotech companies across global regulatory environments