Safety & PV Specialist II - Literature Case Processing

About the role

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals.

What you'll do

• Enter information into PV quality and tracking systems for receipt and tracking of ICSRs
• Process literature-derived ICSRs according to SOPs and project-specific safety plans
• Evaluate case data for completeness, accuracy, and regulatory reportability
• Conduct data entry, coding, narrative writing, and follow-up activities as required
• Perform comprehensive literature screening, review, and Medical Literature Monitoring (MLM) activities to identify and process potential adverse events

What you need

• 4–7 yrs of experience
• Excel
• Clinical research
• Data entry
• Pharmacovigilance
• MS Office
• PowerPoint
• B.Pharm or M.Pharm or BDS

Good to have

• SOP writing
• Customer success