Safety & Pharmacovigilance Coordinator (1+ Year Experience In Ct Or Literature Data Entry)
Syneos Health
Multiple Locations
On-site
Monitor and route safety information
Record icsr documentation
Redact patient-identifying information
Monitor and route incoming safety information to the appropriate project teams
Job Summary
Monitor and route incoming safety information to the appropriate project teams.
Perform accurate and timely data entry into the safety database in accordance with customer-specific guidelines and company standards.
Maintain a working knowledge of SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCP, ICH guidelines, GVP modules, study/program plans, and the drug development process.
Matching Summary
Monitor and route incoming safety information to the appropriate project teams.
Skills & Requirements
Must-have
Monitor and route safety information
Record ICSR documentation
Redact patient-identifying information
Data entry into safety database
Assist with case file creation and maintenance
Maintain knowledge of SOPs and regulations
Nice-to-have
Passionate problem solvers
Innovating as a team
Agile and driven to accelerate delivery
Authentically be yourself
Diversity of thoughts and backgrounds
Key Requirements
1+ Year Experience in CT or Literature Data Entry
Healthcare professional by education: B.Pharm / M.Pharm / PharmD / BDS