Safety & PV Specialist I - Medical Device & Product Quality

Roles & Responsibilities
ICSR Processing & Case Review
• Perform end-to-end ICSR processing in accordance with SOPs and project safety plans
• Conduct quality review of ICSRs to ensure completeness and regulatory compliance
• Perform medical coding of adverse events, medical history, concomitant medications, and laboratory data using MedDRA and relevant dictionaries
• Prepare comprehensive and medically accurate narrative summaries
• Manage follow-up queries to obtain complete and accurate case information
• Identify and manage duplicate ICSRs
Regulatory Reporting & Compliance
• Support xEVMPD validation and submission activities
• Contribute to SPOR / IDMP-related initiatives
• Maintain safety tracking logs and ensure timely regulatory submissions
• Support audit readiness and regulatory inspection activities
• Ensure adherence to SOPs, GVP, ICH-GCP, and global safety regulations
• Assist in clinical trial and post-marketing safety reporting activities

Qualification
• B.Pharm (Bachelor of Pharmacy) / M.Pharm (Master of Pharmacy) / PharmD / BDS / BMS / MBBS
(B.Sc / M.Sc not eligible)

Experience
• 2.5 – 4 years of pharmacovigilance experience
• Minimum 1 year of exclusive Product Quality Complaint (PQC) case handling
• Experience in medical research safety cases
• Hands-on experience with Argus / ARISg safety database
• Experience in clinical trial and/or post-marketing safety reporting

Skills
• Strong understanding of global pharmacovigilance regulations
• Excellent organizational and prioritization skills
• High level of accuracy with strong compliance focus
• Effective stakeholder coordination and communication abilities
• Ability to work in a deadline-driven environment
• Proficiency in Microsoft Office applications

About the Company
Syneos Health is a global biopharmaceutical solutions organization operating across 110+ countries, supporting clinical development, medical affairs, and commercialization services worldwide.