PHARMAFull-time
Safety & PV Specialist I (Russian Fluent) - India
DELHI NCR (IN)HYBRIDPOSTED: 8/14/2026
PHARMAFull-time
HIRING ORGANIZATIONSYNEOS HEALTHBiopharmaceutical / Healthcare Services
ROLE DEFINITION & RESPONSIBILITIES
Process Individual Case Safety Reports (ICSRs) in compliance with SOPs and regulatory safety plans.
Perform triage, data entry, medical coding (MedDRA), narrative writing, and query follow-up.
Review literature for safety, maintain drug dictionaries, manage duplicate ICSRs, and support xEVMPD and SPOR/IDMP activities.
Ensure timely submission of expedited safety reports and upload documents to the Trial Master File (TMF) and PSMF.
Provide quality review of ICSRs in Russian and English following ICH-GCP and GVP guidelines.
REQUIRED VERIFIED SKILLS
Pharmacovigilance
ICSR Processing
Russian Fluency
MedDRA Coding
Safety Database
GVP
ICH-GCP
xEVMPD
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
ORGANIZATION CONTEXT & CULTURE
Syneos Health is a leading fully integrated biopharmaceutical solutions organization. They provide end-to-end clinical and commercial solutions designed to accelerate the development and commercialization of new therapies worldwide. The company combines clinical development, medical affairs, and commercialization expertise to help clients bring innovative treatments to patients faster.
TEAM SIZE: 25,000+ employees
INDUSTRY: Biopharmaceutical / Healthcare Services
RECOMMENDED TRAINING
1/5
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