Safety & PV Specialist

Role & Responsibilities

• Perform ICSR case processing, booking, triage, and data entry.
• Conduct quality review (QC) of ICSRs as per SOPs and GVP.
• Enter, code, and review safety data in Argus / ARISg / LSMV.
• Prepare accurate case narratives and follow up on queries.
• Identify and manage duplicate safety cases.
• Perform MedDRA coding for events, indications, and products.
• Handle literature screening and drug dictionary maintenance.
• Support xEVMPD, SPOR / IDMP activities.
• 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.
• 3+ years of experience in Pharmacovigilance case processing.
• Mandatory experience in Clinical Trial, PMS, and Spontaneous cases.
• Strong working knowledge of Argus Safety Database.
• Proficiency in MedDRA coding and medical terminology.
• Excellent communication, accuracy, 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.