Safety Data Coordinator

Role & Responsibilities

• Perform ICSR case processing and data entry.
• Manage safety cases, triaging, and quality checks.
• Handle literature screening, drug dictionary maintenance, and follow-up on queries.
• Support the preparation of safety reports and documentation for audits.
• Support xEVMPD and IDMP activities as required.
• Ensure documentation compliance with TMF and PSMF.
• Participate in internal and external PV audits.
• Ensure adherence to ICH-GCP, GVP, and global safety regulations.

Qualifications & Skills

• Bachelor’s degree in Life Sciences / Pharmacy / Nursing.
• 1 – 2.6 years of experience in Pharmacovigilance.
• Familiarity with Argus Safety Database and safety case processing.
• Strong attention to detail and multi-tasking ability.
• Proficiency in MedDRA coding and medical terminology.
• Excellent communication and time-management skills.

Why Join Syneos Health?

• Work with a leading global organization involved in 94% of novel FDA-approved drugs.
• Exposure to international clinical trials and post-marketing safety programs.
• Career development with structured training and mentoring.
• Inclusive culture promoting diversity and well-being.
• Opportunity to work on cutting-edge drug safety projects.