Job Title: Safety & Pharmacovigilance (PV) Specialist I
Company: Syneos Health
Location: Gurugram / Hyderabad (Office-based)
Experience Required: PV Specialist I: Minimum 2.6 years
PV Specialist II: Minimum 4 years
Educational Qualification: B.Pharm / M.Pharm / BDS / BMS / MBBS
(Note: BSc/MSc not eligible)
About the Company:
Syneos Health is a fully integrated life sciences organization that supports drug development and commercialization. It collaborates with pharmaceutical innovators to accelerate clinical and safety solutions across the product lifecycle.
Key Responsibilities:
1. Case Processing & Data Management
Enter and track Individual Case Safety Reports (ICSRs) in PV systems
Perform data entry into safety databases
Ensure accuracy, completeness, and regulatory compliance
2. ICSR Handling
Triage ICSRs and assess reportability
Process cases as per SOPs and safety plans
Identify and manage duplicate cases
Perform quality review of ICSRs
3. Medical Coding & Documentation
Code:
Adverse events
Medical history
Concomitant medications
Use MedDRA coding for standardization
Maintain drug dictionaries
4. Narrative Writing & Query Management
Prepare detailed case narratives
Identify missing information and raise queries
Follow up until queries are resolved
5. Regulatory Reporting
Assist in expedited reporting as per global regulations
Ensure timely submission of safety reports
Support xEVMPD submissions and product record validation
6. Literature & Safety Monitoring
Perform literature screening and review
Identify safety signals from published data
7. Compliance & Documentation
Maintain:
Trial Master File (TMF)
Pharmacovigilance System Master File (PSMF)
Ensure compliance with:
SOPs & Work Instructions
ICH-GCP, GVP guidelines
Global regulatory requirements
8. Advanced PV Activities
Handle SPOR / IDMP-related tasks
Perform manual recoding of products/substances
9. Collaboration & Audits
Work with internal and external teams
Participate in audits and inspections
Maintain professional communication
Key Skills Required:
Pharmacovigilance & ICSR processing
Medical coding (MedDRA)
Attention to detail & data accuracy
Regulatory knowledge (ICH, GVP, GCP)
Communication & teamwork
Problem-solving and analytical thinking
Work Environment & Culture:
Strong focus on career growth and training
Inclusive and collaborative work culture
Opportunity to work on global clinical projects
Additional Notes:
Immediate joiners preferred
Responsibilities may vary based on project requirements
Company follows global compliance and equal opportunity policies
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