If you’re an experienced pharmacovigilance professional looking to advance in global drug safety, this opportunity at Syneos Health could be a strong next move. The company is hiring Safety & PV Specialist II (Night Shift) professionals across India for office-based roles in Hyderabad, Gurugram, and Pune.
With increasing demand for drug safety experts, this role offers exposure to global regulatory frameworks, ICSR lifecycle management, and advanced PV systems.
Job Overview
- Role: Safety & PV Specialist II
- Company: Syneos Health
- Job Type: Full-time
- Work Mode: Office-based
- Shift: Night Shift
- Locations: Hyderabad, Gurugram, Pune
- Experience Required: Minimum 4 years (PV domain)
- Qualification: B.Pharm / M.Pharm / BDS / BMS / MBBS
- Job ID: 25107344
Key Responsibilities
As a Safety & PV Specialist II, you will be responsible for end-to-end pharmacovigilance operations, including:
- Processing and tracking Individual Case Safety Reports (ICSRs)
- Performing ICSR triage, data entry, and quality checks
- Coding adverse events using MedDRA and drug dictionaries
- Writing detailed narrative summaries
- Handling duplicate case detection and reconciliation
- Performing literature screening and safety review
- Supporting xEVMPD submissions and IDMP/SPOR activities
- Ensuring compliance with GVP, ICH, and global regulatory guidelines
- Managing TMF documentation and audit readiness
- Participating in query management and follow-ups
This role demands strong expertise in pharmacovigilance case processing, safety databases, and regulatory compliance.
Eligibility Criteria
Educational Qualification
- B.Pharm / M.Pharm
- BDS / BMS / MBBS
(Note: BSc/MSc candidates are not eligible)
Experience
- Minimum 4 years in Pharmacovigilance
- Hands-on experience in ICSR processing and MedDRA coding preferred
Additional Requirements
- Willingness to work in night shifts
- Strong understanding of global safety regulations (FDA, EMA, ICH)
- Experience with Argus/ArisG or similar safety databases is a plus
Why Join Syneos Health?
Syneos Health is a globally recognized CRO with strong involvement in drug development and safety:
- Worked on 94% of FDA-approved drugs (last 5 years)
- Exposure to global pharmacovigilance projects
- Strong focus on career growth and internal mobility
- Continuous technical and therapeutic training
- Inclusive and collaborative work environment
Salary & Benefits
- Estimated Salary Range: โน6 LPA โ โน10 LPA (based on experience)
- Night shift allowances
- Health and wellness benefits
- Learning & development programs
- Performance-based incentives
How to Apply
