Syneos Health is hiring for Safety & Pharmacovigilance (PV) roles in India, including a remote Safety & PV Ops Specialist II and an office-based Sr. Safety & PV Specialist (Night Shift). These roles are ideal for professionals with strong pharmacovigilance operations, ICSR processing, and regulatory compliance experience.

With increasing demand for drug safety professionals, these openings offer excellent exposure to global PV systems, FDA/EMA regulations, and clinical safety operations.

🔍 Job Overview

1. Safety & PV Ops Specialist II (Remote)

• Location: India (Remote – Pre-approved)
• Experience: 3+ years in Pharmacovigilance
• Type: Full-time

2. Sr. Safety & PV Specialist (Night Shift)

• Location: Hyderabad, Gurugram, Pune
• Experience: 6+ years in PV (ICSR + QC mandatory)
• Shift: Night Shift
• Type: Full-time

🧪 Key Responsibilities (PV Operations & Drug Safety)

Safety & PV Ops Specialist II

• Maintain PV documentation repository (training, audits, metrics)
• Ensure compliance with SOPs, ICH, FDA & EMA guidelines
• Support quality assurance, CAPA, and audit readiness
• Manage safety databases, MedDRA & WHO Drug Dictionary updates
• Generate PV reports, listings, and regulatory outputs
• Support proposal development & financial tracking
• Provide training & LMS support within PV teams

Sr. Safety & PV Specialist

• Perform ICSR case processing & quality checks
• Conduct data entry, coding (MedDRA), and narrative writing
• Handle expedited reporting & regulatory submissions
• Perform literature screening & signal detection support
• Manage duplicate cases & safety database updates
• Support xEVMPD, IDMP, and SPOR activities
• Ensure TMF and PV system compliance

🎓 Qualifications & Eligibility

Safety & PV Ops Specialist II

• Minimum 3+ years PV experience
• Strong technical writing skills
• Experience with safety databases & documentation
• Proficiency in MS Office (Excel, PowerPoint, PDFs)

Sr. Safety & PV Specialist

• Education: B.Pharm / M.Pharm / MBBS / BDS / BMS
• Experience: 6+ years in PV
• Mandatory ICSR processing + QC experience
• Knowledge of GVP, ICH, GCP guidelines

💰 Salary (Estimated Range)

• Safety & PV Ops Specialist II: ₹6 – ₹10 LPA
• Sr. Safety & PV Specialist: ₹10 – ₹18 LPA

(Based on industry benchmarks for pharmacovigilance jobs in India)

🌟 Why Join Syneos Health?

• Work on 94% of FDA-approved drugs (last 5 years)
• Exposure to global clinical trials & safety systems
• Strong career growth & training programs
• Opportunity in remote + hybrid PV roles
• Collaborative global CRO environment

📩 How to Apply

Application Link For Safety & PV Ops Specialist II

Application Link For Sr. Safety & PV Specialist