Pharmacovigilance Specialist

Syneos Health, Inc.; Hyderabad, Gurugram District, Delhi; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Syneos Health, Inc. is seeking an experienced Safety & Pharmacovigilance Specialist II (ICSR) to join our team in India. The role focuses on end-to-end ICSR case handling with initial data entry and progression to quality review, ensuring accuracy and timeliness in a regulated environment.

You will work on spontaneous, clinical trial, and literature cases, applying global PV guidelines and SOPs while collaborating with cross-functional teams to deliver high-quality submissions.

Qualifications

• 2.6–6.5 years of experience in ICSR case processing.
• Hands-on experience with Argus and ArisG safety databases.
• Strong understanding of pharmacovigilance processes and regulatory compliance.
• Experience in data entry, case processing, and workflow management.

Responsibilities

• End-to-end ICSR case processing (Spontaneous / Clinical Trial / Literature).
• Accurate data entry as part of the core responsibilities (initial phase).
• Handle case workflows including triage, data entry, coding, narrative writing, and submission readiness.
• Ensure compliance with global pharmacovigilance guidelines, SOPs, and regulatory requirements.
• Perform quality checks (QC) on processed cases based on experience and performance.
• Maintain high standards of accuracy, quality and timelines in deliverables.
• Collaborate with internal teams to ensure smooth case processing and reporting.

Skills

ICSR processing

Data entry

Pharmacovigilance

Compliance

QA/QC

Tools

Argus

ArisG

Job description

Job Title: Safety & Pharmacovigilance Specialist II (ICSR)

Location: Gurugram / Hyderabad (Work from Office No Hybrid)

Shift: Regular Shift

Experience: 2-7 yrs

Role Overview

We are hiring experienced Safety & Pharmacovigilance Specialists I/ II with strong expertise in ICSR case processing. The role focuses on end-to-end case handling, with initial involvement in data entry and progression into quality review activities.

Key Responsibilities

• Perform end-to-end ICSR case processing (Spontaneous / Clinical Trial / Literature cases)
• Execute accurate data entry activities as part of core responsibilities (initial phase)
• Handle case workflows including triage, data entry, coding, narrative writing, and submission readiness
• Ensure compliance with global pharmacovigilance guidelines, SOPs, and regulatory requirements
• Perform quality checks (QC) on processed cases based on experience and performance
• Maintain high standards of accuracy, quality, and timelines in deliverables
• Collaborate with internal teams to ensure smooth case processing and reporting.

Required Skills & Experience

• 2.6-6.5years of relevant experience in ICSR case processing
• Hands‑on experience with Argus / ArisG safety databases
• Strong understanding of pharmacovigilance processes and regulatory compliance
• Experience in data entry, case processing, and workflow management
• High attention to detail and quality orientation