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Sr. Safety & Pv Specialist (Night Shift)

Syneos Health
Syneos Health
6+ years
Not Disclosed
Gurgaon, Hyderabad, Pune, India
1 May 8, 2026
Job Description
Job Type: Full Time Education: M.Pharm/B.Pharm or M.Sc. Skills: Medical Billing, Medical Coding, Medical Terminology, mRS and EQ-5D-5L., Narrative Writing, Research & Development, Technical Skill

Sr. Safety & PV Specialist (Night Shift)
Location: Pune / Hyderabad / Gurugram
Company: Syneos Health
Job ID: 25107397
Job Type: Full-Time
Shift: Night Shift
Industry: Pharmacovigilance / Drug Safety / Clinical Research


About the Company

Syneos Health is a globally recognized full-service life sciences organization focused on accelerating customer success across clinical development, medical affairs, and commercialization. The company partners with pharmaceutical, biotechnology, and healthcare innovators to support safer, faster, and more efficient drug development worldwide.

With over 25,000 professionals globally, Syneos Health combines scientific expertise, operational excellence, and patient-focused innovation to deliver advanced healthcare and pharmacovigilance solutions.


Job Overview

Syneos Health is hiring experienced professionals for the role of Sr. Safety & PV Specialist (Night Shift). The selected candidate will be responsible for pharmacovigilance operations, ICSR processing, quality review activities, safety database management, and regulatory safety reporting in compliance with global pharmacovigilance standards.

This role is ideal for candidates with extensive experience in ICSR case processing, quality control (QC), MedDRA coding, safety reporting, and pharmacovigilance operations within pharmaceutical, CRO, or healthcare environments.


Key Responsibilities

  • Process Individual Case Safety Reports (ICSRs) according to SOPs and project safety plans
  • Perform triage and evaluation of ICSR data for:
    • Completeness
    • Accuracy
    • Regulatory reportability
  • Enter and maintain safety data within pharmacovigilance databases
  • Code:
    • Adverse events
    • Medical history
    • Concomitant medications
    • Diagnostic tests
    • Indication terms using MedDRA
  • Prepare and compile narrative summaries for safety cases
  • Perform follow-up activities and query management to obtain missing safety information
  • Support expedited regulatory safety reporting activities
  • Conduct literature screening and safety review activities
  • Manage:
    • Drug dictionaries
    • MedDRA coding
    • Duplicate ICSR identification
    • Product and substance recoding activities
  • Perform validation and submission of xEVMPD product records
  • Support SPOR / IDMP-related pharmacovigilance activities
  • Conduct Quality Check (QC) review of ICSRs
  • Ensure submission of required documentation to:
    • Trial Master File (TMF)
    • Pharmacovigilance System Master File (PSMF)
  • Maintain compliance with:
    • GCP Guidelines
    • ICH Guidelines
    • GVP standards
    • SOPs and Work Instructions
    • Global drug and biologics regulations
  • Participate in audits and inspection readiness activities
  • Collaborate effectively with internal teams, sponsors, and external stakeholders

Required Qualifications

Candidates must possess any of the following qualifications:

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

Note:
Candidates with B.Sc. or M.Sc. qualifications are not eligible for this role.