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Safety & Pharmacovigilance Coordinator
Syneos Health
Gurugram / Hyderabad
1+ Year
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 across more than 110 countries with over 29,000 employees and has contributed to the development of many FDA and EMA approved medicines.
📌 Job Overview
- Role: Safety & Pharmacovigilance Coordinator
- Company: Syneos Health
- Location: Gurugram / Hyderabad
- Experience: Minimum 1 Year
- Department: Pharmacovigilance / Drug Safety
- Employment Type: Full-Time
- Shift: Rotational
🔬 Key Responsibilities
- Monitor and route incoming safety information to PV teams.
- Record and track Individual Case Safety Reports (ICSRs).
- Perform pharmacovigilance data entry in safety databases.
- Redact patient-identifying information as per ICH-GCP and GVP guidelines.
- Create and maintain safety case files and documentation.
- Support literature and clinical trial safety case processing.
- Coordinate translation of safety documents.
- Follow SOPs and maintain compliance with global PV regulations.
- Support query follow-ups and safety submissions.
🎓 Eligibility Criteria
- B.Pharm
- M.Pharm
- PharmD
- BDS
Experience Required:
- Minimum 1 year experience in pharmacovigilance
- Experience in ICSR data entry or safety case processing
- Exposure to literature cases or clinical trial safety cases preferred
💻 Required Skills
- Knowledge of pharmacovigilance safety databases
- Medical terminology understanding
- MS Office (Word, Excel, PowerPoint, Outlook)
- Strong documentation and accuracy
- Teamwork and communication skills
⭐ Benefits of Working at Syneos Health
- Exposure to global pharmacovigilance operations
- Career growth in drug safety and clinical research
- Training and professional development programs
- Collaborative international work environment
- Experience with global PV regulations
🎯 Pharmacovigilance Interview Preparation Tips
- Understand ICSR processing workflow
- Learn MedDRA coding basics
- Understand SAE and SUSAR reporting
- Review global PV regulations (ICH, GVP)
Helpful learning resources:
📌 Note Before You Apply:
Kindly read the entire job description carefully before applying. Ensure your pharmacovigilance experience matches the role requirements.
Kindly read the entire job description carefully before applying. Ensure your pharmacovigilance experience matches the role requirements.
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