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Hiring Safety & PV Specialist
Syneos Health
Gurugram
2.5–4 Years
Pharmacovigilance
Clinical Safety
🏢 About Syneos Health
Syneos Health is a global biopharmaceutical solutions organization supporting clinical development, medical affairs, and commercialization services. The company operates in more than 110 countries and has contributed to the development of 94% of recently approved FDA drugs and 95% of EMA-authorized medicines.
📌 Job Overview
- Role: Safety & Pharmacovigilance Specialist I
- Company: Syneos Health
- Location: Gurugram, India
- Experience: 2.5 – 4 Years
- Department: Clinical Safety / Pharmacovigilance
- Employment Type: Full-Time
🔬 Key Responsibilities
- Process Individual Case Safety Reports (ICSRs)
- Enter and manage safety data in Argus or ARISg databases
- Perform MedDRA coding for adverse events
- Write safety narratives and perform quality checks
- Identify duplicate safety cases and resolve discrepancies
- Handle Product Quality Complaint (PQC) safety cases
- Support expedited regulatory safety reporting
- Maintain documentation for TMF and PSMF
- Perform literature review for adverse event monitoring
- Support pharmacovigilance audits and inspection readiness
🎓 Eligibility Criteria
- B.Pharm
- M.Pharm
- PharmD
- BDS
- BMS
- MBBS
Experience Requirements:
- 2.5 – 4 years pharmacovigilance experience
- Minimum 1 year experience handling Product Quality Complaint cases
- Hands-on experience with Argus or ARISg safety databases
- Knowledge of MedDRA coding
- Understanding of clinical trial safety reporting
⭐ Benefits of Working at Syneos Health
- Exposure to global pharmacovigilance programs
- Structured career development and training
- Competitive salary and benefits
- Opportunity to work on global clinical trials
- Collaborative international work environment
🎯 Pharmacovigilance Interview Preparation Tips
If you are preparing for pharmacovigilance interviews, review the following concepts:
- ICSR processing workflow
- MedDRA coding principles
- Argus Safety / ARISg database usage
- Serious adverse event (SAE) reporting
- Global PV regulations (ICH, GVP)
Helpful learning resources:
📌 Note Before You Apply:
Kindly read the job description carefully and ensure your pharmacovigilance experience matches the role requirements before submitting your application.
Kindly read the job description carefully and ensure your pharmacovigilance experience matches the role requirements before submitting your application.
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