Safety & PV Coordinator

Roles & Responsibilities
• Process, triage, and track Individual Case Safety Reports (ICSRs) in PV systems
• Assess cases for completeness, accuracy, and regulatory reportability
• Code adverse events, medical history, medications, and tests using MedDRA
• Prepare clear and compliant case narratives and manage follow-ups
• Perform duplicate case identification and management
• Conduct literature screening and safety reviews
• Support xEVMPD product record validation and SPOR/IDMP activities
• Ensure documentation is filed in TMF and PV System Master File
• Maintain compliance with SOPs, ICH-GCP, GVP, and global PV regulations
• Support audits and inspections and collaborate with cross-functional teams

Qualification
• B.Pharm or M.Pharm (mandatory)

Experience
• Minimum 1 year of experience in Post-Marketing Safety and spontaneous case processing
• Hands-on experience with LSMV or Argus safety database

Skills
• Strong knowledge of Pharmacovigilance and ICSR processing
• MedDRA coding and safety database expertise
• Understanding of clinical trial phases II–IV and post-marketing safety
• Proficiency in MS Office and strong documentation skills
• Excellent communication, organization, and attention to detail

About the Organization
Syneos Health® is a global biopharmaceutical solutions organization delivering integrated clinical, medical affairs, and commercial services. With a strong focus on patient-centricity and innovation, Syneos Health partners with leading pharma companies to accelerate the delivery of life-changing therapies worldwide.