Safety & Pharmacovigilance Coordinator

Roles & Responsibilities
• Monitor and route incoming safety information to appropriate project teams
• Record and track ICSR documentation as per sponsor/customer specifications
• Perform accurate and timely data entry into safety databases
• Process Literature and Clinical Trial (CT) cases as per regulatory guidelines
• Redact patient-identifying information in compliance with ICH-GCP and GVP requirements
• Assist in case file creation, tracking, reconciliation, and maintenance (electronic & paper)
• Support safety submissions and query follow-up activities
• Manage translation processes for source safety documents
• Maintain compliance with SOPs, WIs, global PV regulations, and study plans

Qualification
• B.Pharm / M.Pharm / PharmD / BDS

Experience
• Minimum 1 year of Pharmacovigilance experience in full data entry/case processing role (mandatory)
• Experience in Literature and Clinical Trial (CT) case processing preferred
• Exposure to safety databases and medical terminology preferred

Skills
• Strong knowledge of pharmacovigilance and ICSR processing
• Understanding of ICH-GCP, GVP modules, and global safety regulations
• Proficiency in MS Office and document management systems
• Excellent written and verbal communication skills
• High attention to detail and documentation accuracy
• Ability to manage multiple tasks in a fast-paced environment
• Strong teamwork and organizational skills
• Flexibility to work in rotational shifts

About the Organization
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization operating in over 110 countries with 29,000+ employees. The company supports clinical development and commercialization, contributing to 94% of Novel FDA Approved Drugs and 95% of EMA Authorized Products in recent years, accelerating therapies that change lives worldwide.