Syneos Health has announced recruitment for Safety & PV Specialist I positions in India. The company is hiring experienced pharmacovigilance professionals for two office-based roles in Hyderabad and Gurugram. Candidates with experience in ICSR processing, Product Quality Complaint (PQC), Argus/ARISg, MedDRA coding, and global pharmacovigilance regulations are encouraged to apply.

These opportunities are ideal for professionals with 2.5–4 years of pharmacovigilance experience, particularly those having hands-on experience in PQC case handling and medical research safety cases.

Job Overview

Available Roles

• Safety & PV Specialist I – Medical Device & PQC (Hyderabad)
• Safety & PV Specialist I – PQC (Gurugram)

Key Responsibilities

The selected candidates will be responsible for:

• Perform end-to-end ICSR processing.
• Review and triage adverse event reports.
• Enter safety cases into Argus or ARISg safety database.
• Code adverse events using MedDRA and related dictionaries.
• Prepare medically accurate case narratives.
• Manage duplicate cases and perform quality review.
• Support expedited regulatory safety reporting.
• Handle Product Quality Complaint (PQC) cases.
• Validate xEVMPD records and support SPOR/IDMP activities.
• Perform literature screening and safety review.
• Maintain drug dictionaries and coding activities.
• Ensure compliance with SOPs, GVP, GCP, ICH guidelines and global regulations.
• Support audits and regulatory inspections.
• Maintain Trial Master File (TMF) and Pharmacovigilance System Master File (PSMF) documentation.
• Collaborate with internal and external stakeholders.

Educational Qualification

Applicants should possess any one of the following qualifications:

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

Note: B.Sc and M.Sc candidates are not eligible for these positions.

Experience Required

Candidates should have:

• 2.5–4 years of Pharmacovigilance experience.
• Minimum 1 year of exclusive Product Quality Complaint (PQC) experience.
• Experience handling medical research safety cases.
• Hands-on experience with Argus or ARISg safety database.
• Good understanding of global pharmacovigilance regulations.
• Knowledge of clinical trial safety and post-marketing surveillance.

Required Skills

• ICSR Processing
• Product Quality Complaint (PQC)
• Argus Safety Database
• ARISg
• MedDRA Coding
• Narrative Writing
• Safety Data Management
• Regulatory Reporting
• xEVMPD
• SPOR
• IDMP
• Literature Screening
• Pharmacovigilance Compliance
• Microsoft Office

Why Join Syneos Health?

Syneos Health offers employees:

• Career development opportunities
• Global exposure in pharmacovigilance
• Comprehensive technical training
• Competitive rewards and recognition
• Inclusive and collaborative work environment
• Opportunity to work on global drug development programs

Salary (Expected)

Based on current market standards for professionals with 2.5–4 years of experience, the estimated annual salary is:

₹6,50,000 – ₹10,00,000 per annum (CTC)

Actual compensation may vary depending on skills, experience, and interview performance.

How to Apply

Application Link Safety & PV Specialist I – Medical Device & PQC (Hyderabad)

Application Link Safety & PV Specialist I – PQC (Gurugram)