Safety & PV Specialist I - Medical Device & PQC

Roles & Responsibilities
ICSR Processing & Case Management
• Enter and track ICSRs in PVG quality and tracking systems
• Process ICSRs as per SOPs and project-specific safety plans
• Triage cases for completeness, accuracy, and regulatory reportability
• Perform data entry in Argus / ARISg safety database
• Code adverse events, medical history, concomitant medications, and lab data using MedDRA and relevant dictionaries
• Prepare medically accurate narrative summaries
• Identify missing or inconsistent information and follow up for resolution
• Detect and manage duplicate cases
• Conduct quality review of processed ICSRs

Regulatory Reporting & Compliance
• Support preparation and submission of expedited safety reports as per global regulatory timelines
• Validate and submit xEVMPD product records with appropriate MedDRA coding
• Perform manual recoding of product and substance terms from ICSRs
• Support SPOR / IDMP-related activities
• Maintain safety tracking logs for assigned activities
• Ensure submission of documents to TMF (clinical trials) and PSMF (post-marketing programs)
• Apply global safety regulatory intelligence to reporting activities

Literature, Audit & Collaboration
• Perform literature screening and safety reviews
• Maintain drug dictionaries and support coding updates
• Ensure compliance with SOPs, WIs, GCP, ICH, GVP, and global safety regulations
• Participate in audits and support inspection readiness activities
• Collaborate effectively with internal and external stakeholders

Qualification
• B.Pharm (Bachelor of Pharmacy) / M.Pharm (Master of Pharmacy) / PharmD (Doctor of Pharmacy) / 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-related safety cases
• Hands-on experience with Argus / ARISg safety database
• Knowledge of Clinical Trial Phases II–IV and/or post-marketing safety

Skills
• Strong understanding of global pharmacovigilance regulations and reporting requirements
• Proficiency in Microsoft Office applications
• Strong analytical and documentation skills
• Excellent communication and stakeholder coordination abilities
• High attention to detail and compliance-focused approach

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