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Hiring Safety & PV Specialists
Hyderabad
1–3 Years
ICSR / PMS
Pharmacovigilance
🏢 About Company
Syneos Health is a leading global Contract Research Organization (CRO) supporting clinical development, commercialization, and pharmacovigilance operations. The company contributes to a large percentage of global drug approvals and works with top pharmaceutical companies worldwide.
💼 Job Overview
- Role: Safety & PV Coordinator / Specialist I / II
- Location: Hyderabad (Office-based)
- Qualification: B.Pharm / M.Pharm
- Experience: 1.5 – 3 Years
- Domain: Pharmacovigilance (Spontaneous Cases & PMS)
- Database: LSMV / Argus (preferred)
📌 Key Responsibilities
- Perform ICSR case processing from intake to closure
- Case triage, data entry, evaluation, and follow-ups
- MedDRA coding for events and medical history
- Prepare narrative summaries
- Duplicate case detection & reconciliation
- Literature screening and signal detection
- xEVMPD submissions and validation
- Maintain drug dictionaries & PV documentation
- Support audits, inspections, and compliance activities
- Ensure adherence to ICH-GCP & GVP guidelines
🎓 Eligibility Criteria
- B.Pharm / M.Pharm (Mandatory)
- 1–3 years experience in Pharmacovigilance
- Hands-on experience in PMS & spontaneous cases
- Knowledge of safety databases (Argus / LSMV)
- Strong understanding of PV regulations
💻 Required Skills
- ICSR lifecycle management
- MedDRA coding
- Safety database handling
- Regulatory compliance (ICH-GVP)
- Attention to detail
📚 Learn Important Concepts:
💰 Salary & Benefits
- ₹4 – ₹8 LPA (Estimated)
- Global project exposure
- Strong PV career growth
- Work with international clients
🎯 Interview Preparation
- Revise ICSR lifecycle & case processing
- Understand MedDRA hierarchy
- Prepare PMS vs Clinical Trials differences
- Practice real case scenarios
🧠 Practice Quiz:
📌 Note Before You Apply:
Kindly read the entire job description carefully before applying. Ensure your CV highlights ICSR processing, MedDRA coding, and safety database experience.
Kindly read the entire job description carefully before applying. Ensure your CV highlights ICSR processing, MedDRA coding, and safety database experience.
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