Safety & Pharmacovigilance Coordinator

Roles & Responsibilities
• Monitor and route incoming safety information to project teams
• Perform accurate ICSR data entry and case processing in safety databases
• Track and record all safety documentation per sponsor guidelines
• Redact patient-identifiable data as per ICH-GCP and GVP requirements
• Support literature and clinical trial (CT) case processing
• Assist in translation coordination for safety source documents
• Support query follow-up and safety submission processes
• Maintain case files (electronic and paper)
• Conduct daily workflow reconciliation activities
• Follow SOPs, WIs, global PV regulations, and study plans

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

Experience
• Minimum 1 year of Pharmacovigilance case processing or full data entry role (mandatory)
• Experience in Clinical Trial (CT) cases and Literature cases preferred
• Knowledge of safety databases and medical terminology preferred

Skills
• Strong documentation accuracy
• Ability to manage multiple tasks
• Team collaboration
• MS Office (Word, Excel, PowerPoint, Outlook) proficiency
• Familiarity with document management systems
• Understanding of ICH Guidelines, GVP Modules, and global drug safety regulations

About The Company
Syneos Health is a global, mid-sized Contract Research Organization (CRO) providing integrated biopharmaceutical solutions to help customers accelerate the development of their drugs. With operations in over 110 countries, Syneos Health has been involved in 94% of novel FDA-approved drugs in the last five years, offering unparalleled exposure to global regulatory standards and drug safety regulations.