Safety & PV Specialist I Job at Syneos Health (Hyderabad, Gurugram, Pune)
Syneos Health is hiring Safety & PV Specialist I professionals for office-based pharmacovigilance and drug safety operations roles in India.
This opportunity is ideal for candidates with experience in:
- ICSR Processing
- Drug Safety Operations
- MedDRA Coding
- Safety Databases
- Pharmacovigilance Compliance
- Regulatory Safety Reporting
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📋 Job Overview
- Role: Safety & PV Specialist I
- Company: Syneos Health
- Locations: Hyderabad, Gurugram, Pune
- Job Type: Full-Time
- Work Mode: Office-Based
- Experience Required: Minimum 2.6 Years
- Department: Clinical Solutions / Drug Safety
- Salary: ₹3.5 – ₹8 LPA (Estimated)
🧑💻 Experience Requirements
- Safety & PV Specialist I: Minimum 2.6+ Years
- Safety & PV Specialist II: 4+ Years
✔ Candidates with hands-on pharmacovigilance experience in ICSR processing and safety operations are preferred.
❌ BSc / MSc candidates are not eligible for this role.
📌 Key Responsibilities
- Perform end-to-end ICSR case processing
- Handle case triage and data validation activities
- Perform MedDRA coding for adverse events and medications
- Prepare narrative summaries for safety cases
- Conduct duplicate case detection and reconciliation
- Perform literature screening and signal identification
- Support xEVMPD submissions and SPOR/IDMP activities
- Maintain compliance with ICH-GCP, GVP, FDA, and EMA guidelines
- Contribute to Trial Master File (TMF) documentation
- Participate in audits and quality reviews
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🎓 Eligibility Criteria
- B.Pharm
- M.Pharm
- PharmD
- BDS
- BMS
- MBBS
💡 Required Skills
- Strong knowledge of pharmacovigilance workflows
- Experience with Argus / ArisG / Safety Databases
- Knowledge of MedDRA coding
- Understanding of ICSR lifecycle
- Strong documentation and compliance mindset
- Attention to detail and analytical skills
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🌟 Benefits of Working at Syneos Health
- Exposure to global pharmacovigilance projects
- Career growth in drug safety and PV operations
- Structured training and development programs
- Work with FDA & EMA regulated products
- Collaborative and inclusive work culture
- Opportunity to work with a leading global CRO
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🚀 Job Application Link
Kindly read the complete job description carefully before applying. Make sure your pharmacovigilance experience aligns with ICSR processing, MedDRA coding, and safety database requirements.
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