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Sr. Safety & Pv Specialist (Night Shift) – Pharmacovigilance & Drug Safety Operations

Syneos Health
Syneos Health
6+ years
preferred by company
Gurgaon, Hyderabad, Pune, India
1 May 12, 2026
Job Description
Job Type: Full Time Education: M.Pharm/B.Pharm or M.Sc. Skills: Medical Coding, Medical Terminology, mRS and EQ-5D-5L., Narrative Writing, Research & Development

Sr. Safety & PV Specialist (Night Shift) – Pharmacovigilance & Drug Safety Operations

Company: Syneos Health
Job Title: Sr. Safety & PV Specialist (Night Shift)
Location: Hyderabad / Gurugram / Pune, India
Work Model: Office-Based
Job ID: 25107397
Department: Clinical Solutions / Safety & Pharmacovigilance


About the Role

Syneos Health is hiring a Sr. Safety & PV Specialist (Night Shift) for its global Safety & Pharmacovigilance Operations team. This opportunity is ideal for experienced pharmacovigilance professionals with strong expertise in ICSR Case Processing, Quality Check (QC), Drug Safety Operations, MedDRA Coding, Regulatory Reporting, and Pharmacovigilance Compliance.

The selected candidate will manage end-to-end ICSR processing, safety data review, narrative writing, regulatory reporting support, safety database activities, and pharmacovigilance quality operations while ensuring compliance with global drug safety standards.

This role is best suited for candidates with minimum 6 years of Pharmacovigilance experience and mandatory ICSR + QC experience.


Key Responsibilities

ICSR Case Processing & Drug Safety Operations

  • Process Individual Case Safety Reports (ICSRs) according to SOPs and project-specific safety plans
  • Perform case triage and evaluate safety reports for:
    • Accuracy
    • Completeness
    • Regulatory reportability
  • Enter safety case data into pharmacovigilance databases
  • Maintain tracking for assigned pharmacovigilance activities

Medical Coding & Safety Review

  • Perform:
    • MedDRA coding
    • Drug coding
    • Medical history coding
    • Concomitant medication coding
    • Test result coding
  • Conduct literature screening and safety review activities
  • Maintain drug dictionaries and safety coding accuracy
  • Identify and manage duplicate ICSRs
  • Perform manual recoding of uncoded product and substance terms

Narrative Writing & Query Management

  • Compile detailed safety narrative summaries
  • Identify missing or incomplete safety information
  • Generate safety queries and perform follow-up until closure
  • Ensure high-quality and accurate safety case documentation

Regulatory Reporting & Compliance

  • Support generation of expedited safety reports within required timelines
  • Assist with:
    • xEVMPD validation and submissions
    • SPOR / IDMP activities
    • Global regulatory safety reporting
  • Ensure compliance with:
    • FDA regulations
    • ICH Guidelines
    • GCP
    • GVP
    • Global pharmacovigilance standards

Quality Review & Documentation Management

  • Perform Quality Check (QC) review of ICSRs
  • Support pharmacovigilance quality assurance activities
  • Ensure relevant documentation is submitted to:
    • Trial Master File (TMF)
    • Pharmacovigilance System Master File
  • Support audit readiness and regulatory inspection preparation

Cross-Functional Collaboration

  • Work closely with:
    • Internal pharmacovigilance teams
    • Project teams
    • Sponsors
    • Quality and regulatory stakeholders
  • Participate in audits and operational meetings
  • Apply safety reporting intelligence to ongoing project activities

Educational Qualification

Candidates must possess one of the following qualifications:

  • B.Pharm
  • M.Pharm
  • BDS
  • BMS
  • MBBS

Note: B.Sc / M.Sc candidates are not eligible.


Required Experience

Mandatory Experience

  • Minimum 6+ years of Pharmacovigilance experience
  • Strong ICSR Case Processing experience
  • Mandatory Quality Check (QC) experience

Preferred Experience Areas

  • Drug Safety Operations
  • Safety narrative writing
  • MedDRA coding
  • Literature screening
  • xEVMPD submissions
  • SPOR / IDMP
  • Safety database management