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Safety & Pv Specialist I (Gurugram-Night Shift)

Syneos Health
2.6+ years
INR 5 LPA – 9 LPA
Gurgaon, Hyderabad, India
1 June 17, 2026
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: CPC Certified, CPT, Data Analysis, Document Management, Life Science, Regulatory Compliance, Waterfall Model, GCP guidelines, HCPCS Level II, ICD-10-CM, ICD-10 CM Codes, CPT-Codes, HCPCS Codes

Safety & PV Specialist I (Gurugram – Night Shift)

Company: Syneos Health
Location: Hyderabad, Telangana, India (Gurugram shift-based role)
Work Mode: Office-Based / Shift-Based (Night Shift)
Employment Type: Full-Time

Job Overview

The Safety & PV Specialist I is responsible for supporting pharmacovigilance case processing activities, including ICSR management, data entry, coding, narrative writing, quality checks, and regulatory reporting. The role ensures compliance with global pharmacovigilance regulations and SOPs while maintaining accurate safety databases and supporting end-to-end drug safety operations in a fast-paced CRO environment.

Key Responsibilities

  • Process Individual Case Safety Reports (ICSRs) as per SOPs and project safety plans.
  • Enter, update, and maintain safety data in pharmacovigilance databases and tracking systems.
  • Perform case triage, completeness checks, and regulatory reportability assessments.
  • Code adverse events, medical history, concomitant medications, and lab tests using MedDRA.
  • Prepare and review narrative case summaries for safety reports.
  • Identify missing information and manage follow-ups to resolve queries.
  • Support expedited and periodic safety reporting in compliance with global regulations.
  • Conduct literature screening and safety-related reviews.
  • Perform duplicate case identification and reconciliation.
  • Support xEVMPD submissions, SPOR/IDMP activities, and product data maintenance.
  • Ensure TMF documentation and PV System Master File compliance.
  • Participate in quality reviews, audits, and inspection readiness activities.
  • Maintain safety tracking systems and ensure timely updates.
  • Collaborate with cross-functional teams in global pharmacovigilance operations.

Required Qualifications

  • B.Pharm / M.Pharm / BDS / BMS / MBBS only (BSc/MSc not eligible)
  • Strong understanding of pharmacovigilance concepts and drug safety processes
  • Knowledge of ICH-GCP, GVP, and global regulatory guidelines
  • Familiarity with safety databases and MedDRA coding
  • Strong documentation and data entry accuracy skills
  • Willingness to work in night shifts

Preferred Qualifications

  • Prior experience in CRO or pharmaceutical pharmacovigilance operations
  • Experience in ICSR case processing or safety database handling
  • Exposure to regulatory submissions or safety reporting systems
  • Understanding of SPOR, IDMP, or xEVMPD processes
  • Audit or inspection support experience

Experience Required

  • Minimum 2.6+ years of experience in Pharmacovigilance / Drug Safety / ICSR processing
  • Experience in case processing, coding, or safety reporting strongly preferred