Welcome Back

Google icon Sign in with Google
OR
I agree to abide by Pharmadaily Terms of Service and its Privacy Policy

Create Account

Google icon Sign up with Google
OR
By signing up, you agree to our Terms of Service and Privacy Policy
Instagram
youtube
Facebook

Sr. Safety & Pv Specialist (Night Shift)

Syneos Health
Syneos Health
6+ years
Not Disclosed
Gurugram, India
1 May 8, 2026
Job Description
Job Type: Full Time Education: M.Pharm/B.Pharm or M.Sc. Skills: Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding

Sr. Safety & PV Specialist (Night Shift)
Location: 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 and fully integrated life sciences organization dedicated to accelerating customer success across clinical development, medical affairs, and commercialization. The company partners with pharmaceutical, biotechnology, and healthcare innovators to support advanced drug development, patient safety, and regulatory excellence worldwide.

With more than 25,000 professionals globally, Syneos Health combines scientific expertise, operational efficiency, and healthcare innovation to deliver impactful clinical 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 reporting, and regulatory compliance support within global drug safety programs.

This role is ideal for candidates with strong expertise in ICSR case processing, Quality Check (QC) activities, MedDRA coding, and pharmacovigilance operations within pharmaceutical, CRO, or healthcare environments.


Key Responsibilities

  • Process Individual Case Safety Reports (ICSRs) according to SOPs and project safety plans
  • Enter and maintain safety data within pharmacovigilance tracking systems and safety databases
  • Perform triage and evaluation of ICSRs for:
    • Completeness
    • Accuracy
    • Regulatory reportability
  • Code:
    • Adverse events
    • Medical history
    • Concomitant medications
    • Diagnostic tests
    • Indication terms using MedDRA
  • Prepare complete narrative summaries for safety cases
  • Conduct follow-up and query management activities to obtain missing safety information
  • Support timely and accurate expedited safety reporting activities
  • Perform literature screening and pharmacovigilance review activities
  • Maintain drug dictionaries and support MedDRA coding activities
  • Validate and submit xEVMPD product records
  • Perform manual recoding of product and substance terms arising from ICSRs
  • Identify and manage duplicate ICSRs
  • Support SPOR / IDMP-related pharmacovigilance activities
  • Conduct Quality Check (QC) review of safety cases
  • Ensure documentation compliance within:
    • Trial Master File (TMF)
    • Pharmacovigilance System Master File (PSMF)
  • Maintain compliance with:
    • GCP Guidelines
    • ICH Guidelines
    • GVP standards
    • SOPs and Work Instructions
    • Global pharmacovigilance regulations
  • Participate in audits and inspection readiness activities
  • Collaborate effectively with project teams, sponsors, and 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.