Job Type: Full Time, Hybrid, Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: ICH guidelines, ICSR Case Processing, Labelling Assessment, MedDRA Coding, mRS and EQ-5D-5L, Triage of ICSRs, WHO DD Coding

Safety & PV Specialist I - PQC

Company: Syneos Health

Location: Gurgaon, India

Job ID: 25107950

Employment Type: Full time

Work Mode: Office-Based

Experience Required: 2.5 – 4 Years

About Syneos Health

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. The company partners with innovators across the drug development and commercialization continuum, helping navigate complexity and accelerate progress.

Syneos Health Focuses On:

Clinical development solutions
Medical affairs
Commercial insights
Patient-focused healthcare innovation

Job Summary

The Safety & Pharmacovigilance Specialist I – Medical Device & PQC is responsible for:

End-to-end Individual Case Safety Report (ICSR) processing
Safety data management
Regulatory reporting support




Compliance with global pharmacovigilance regulations
Product Quality Complaint (PQC) case handling
Medical research-related safety case processing

Key Responsibilities

ICSR Processing & Case Management

Enter information into PVG quality and tracking systems for receipt and tracking of ICSRs.
Process ICSRs according to Standard Operating Procedures (SOPs) and project-specific safety plans.
Triage ICSRs and evaluate:
Completeness
Accuracy
Regulatory reportability
Enter case data into safety databases such as:
Argus
ARISg
Perform coding of:
Adverse events
Medical history
Concomitant medications
Laboratory tests
Code using:
MedDRA
Relevant medical dictionaries
Prepare accurate medical narrative summaries.
Identify missing or inconsistent information.
Follow up on queries until resolution.
Identify and manage duplicate ICSRs.
Perform quality review of ICSRs.
Regulatory Reporting & Compliance

Support preparation and submission of e

📌 Safety & PV Specialist I - PQC (India)
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