PHARMAFull-time
Safety & PV Specialist I
HYDERABAD (IN)ONSITEPOSTED: 8/12/2026
PHARMAFull-time
HIRING ORGANIZATIONSYNEOS HEALTHBiopharmaceutical / Healthcare Services
ROLE DEFINITION & RESPONSIBILITIES
Process Individual Case Safety Reports (ICSRs) according to Standard Operating Procedures (SOPs) and safety plans.
Triage ICSRs, evaluate completeness and accuracy, and determine regulatory reportability.
Enter case details into the safety database, coding medical history, events, and concomitant medications using MedDRA.
Draft comprehensive narrative summaries and manage follow-up queries to resolve missing clinical information.
Support expedited reporting to regulatory authorities and conduct safety literature screenings.
Maintain Trial Master File (TMF) and Pharmacovigilance System Master File (PSMF) documentation in compliance with GCP, GVP, and ICH guidelines.
REQUIRED VERIFIED SKILLS
Pharmacovigilance
ICSR Processing
MedDRA
Safety Database Entry
Narrative Writing
Case Triaging
Regulatory Reporting
GVP
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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