Safety & PV Specialist I - Medical Device & PQC

Roles & Responsibilities
ICSR Processing & Case Management
• Enter and track ICSRs in pharmacovigilance quality systems
• Perform end-to-end ICSR processing as per SOPs and project safety plans
• Triage cases for completeness, accuracy, and regulatory reportability
• Enter and manage case data in Argus / ARISg safety database
• Code adverse events, medical history, concomitant medications, and lab data using MedDRA
• Prepare accurate and comprehensive case narratives
• Follow up on missing or inconsistent information until resolution
• Identify and manage duplicate ICSRs
• Perform quality review of processed cases
Regulatory Reporting & Compliance
• Support preparation and submission of expedited safety reports as per global regulations
• Validate and submit xEVMPD product records with appropriate coding
• Perform manual recoding of product and substance terms from ICSRs
• Support SPOR / IDMP-related regulatory activities
• Maintain safety tracking logs for assigned activities
• Ensure documentation is submitted to TMF (clinical trials) and PSMF (post-marketing) as applicable
• Apply regulatory intelligence to safety reporting activities
Literature, Audit & Collaboration
• Conduct literature screening and safety review
• Maintain drug dictionaries and coding support
• Ensure compliance with SOPs, WIs, GCP, ICH, GVP, and global regulations
• Participate in audits and support inspection readiness
• Collaborate effectively with internal and external stakeholders

Qualification
• (B.Pharm) Bachelor of Pharmacy, (M.Pharm) Master of Pharmacy, (PharmD) Doctor of Pharmacy
• (BDS) Bachelor of Dental Surgery, (BMS) Bachelor of Medical Science, (MBBS) Bachelor of Medicine, Bachelor of Surgery

Experience
• 2.5 – 4 years of pharmacovigilance experience
• Minimum 1 year of exclusive experience in Product Quality Complaint (PQC) case handling
• Experience handling medical research-related safety cases
• Hands-on experience in 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 MedDRA coding and safety database management
• Good knowledge of GCP, ICH, GVP guidelines
• Strong analytical and case evaluation skills
• Proficiency in Microsoft Office applications
• Excellent communication and stakeholder management skills
• Attention to detail and ability to meet strict timelines

About the Company
Syneos Health is a global biopharmaceutical solutions organization operating in over 110 countries with 29,000+ employees. The company partners across clinical development, medical affairs, and commercialization to accelerate therapy delivery and improve patient outcomes worldwide.