Safety Specialist I

About the role

The Safety Specialist I will support Syneos Health’s Clinical Solutions team by managing safety data and ensuring regulatory compliance for drug development projects. This role involves processing Individual Case Safety Reports (ICSRs), maintaining safety databases, and contributing to timely safety reporting.

Key responsibilities

• Enter information into PVG quality and tracking systems for receipt and tracking of ICSR as required.
• Assist in processing ICSR according to Standard Operating Procedures and project‑specific safety plans.
• Triages ICSR, evaluate data for completeness, accuracy, and regulatory reportability.
• Enter data into safety databases, code events, medical history, concomitant medications, and tests.
• Compile narrative summaries and manage queries to obtain missing information.
• Generate expedited safety reports in line with applicable regulatory requirements.
• Perform literature screening, maintain drug dictionaries, and conduct MedDRA coding.
• Validate and submit xEVMPD product records, including coding of indication terms.
• Identify and manage duplicate ICSR and perform quality review of ICSR.

Required profile

• Experience processing ICSR in a pharmacovigilance environment.
• Familiarity with SOPs, regulatory reporting timelines, and safety database entry.
• Ability to conduct literature reviews and manage data queries.
• Strong attention to detail and ability to work with complex safety data.

Required skills

• MedDRA coding
• xEVMPD product record submission
• IDMP knowledge
• SPOR processes
• Use of PVG tracking systems and safety databases

What we offer

• Career development and progression opportunities.
• Supportive line management and technical training.
• Inclusive culture with peer recognition and total rewards program.
• Opportunity to work with a global team of 25,000 colleagues.