Senior Safety & Pharmacovigilance Specialist

About the role

Syneos Health is seeking a Senior Safety & Pharmacovigilance Specialist to lead safety program delivery across clinical trials and post‑marketing activities. The role involves managing individual case safety reports, literature screening, and ensuring compliance with regulatory standards.

Key responsibilities

• Collect, process, and report Individual Case Safety Reports (ICSRs).
• Perform literature screening and review for safety signals.
• Maintain drug dictionaries and conduct drug coding and MedDRA coding.
• Manage data activities including cleaning, validation, duplicate case handling, and quality review.
• Support SPOR/IDMP activities and maintain the xEVMPD product dictionary.
• Prepare expedited and periodic safety reports in line with GCP, GVP, and privacy guidelines.

Required profile

• Extensive experience in safety and pharmacovigilance program delivery.
• Strong knowledge of Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP) regulations.
• Ability to work with complex data sets while ensuring data privacy compliance.
• Proven track record of producing high‑quality safety documentation.

Required skills

• MedDRA coding
• Drug coding and dictionary maintenance
• xEVMPD product dictionary management
• SPOR/IDMP activities
• GCP compliance
• GVP compliance

What we offer

• Career development and progression opportunities.
• Supportive line management and technical training.
• Peer recognition and total rewards program.
• Inclusive culture that encourages authenticity.