PHARMAFull-time
Safety & PV Specialist- Future Roles (India)
HYDERABAD (IN)HYBRIDPOSTED: 8/15/2026
PHARMAFull-time
HIRING ORGANIZATIONSYNEOS HEALTHBiopharmaceutical / Healthcare Services
ROLE DEFINITION & RESPONSIBILITIES
Core Responsibilities
ICSR Processing & Triaging: Log information into PVG quality and tracking systems; triage Individual Case Safety Reports (ICSRs) for completeness, validity, and regulatory reportability according to SOPs and project-specific safety plans.
Safety Data Entry & Medical Coding: Enter case data into safety databases; code adverse events, medical history, concomitant medications, and lab tests using MedDRA and WHO Drug dictionaries; draft exhaustive medical narrative summaries.
Query Management & Expedited Reporting: Identify missing safety information, raise and resolve queries, and support the timely generation and submission of expedited safety reports to global health authorities.
Regulatory Compliance & Dictionary Maintenance: Conduct literature screening for safety signals, perform validation and submission of xEVMPD product records, handle SPOR/IDMP activities, and manage duplicate ICSR reconciliation.
Quality Assurance & TMF Documentation: Perform quality reviews of processed ICSRs and archive trial safety records in the Trial Master File (TMF) or Pharmacovigilance System Master File (PSMF) in adherence to ICH-GCP and GVP guidelines.
Technical & Domain Standards
Strict adherence to global drug/biologic/device safety regulations, ICH guidelines (E2B, E2A), Good Pharmacovigilance Practices (GVP), and SOPs.
Participation in safety data audits and regulatory inspections as required.
REQUIRED VERIFIED SKILLS
Pharmacovigilance
ICSR Processing
MedDRA Coding
Safety Database
Case Narrative Writing
xEVMPD
GVP
ICH-GCP
Triage
Drug Safety
COMPENSATION & REWARDS
₹3.5L - 6.5L per annum
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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