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 Qualifications: B.Pharm/ M.Pharm/ BDS/ BMS/ MBBS (Note: BSc/MSc not eligible)
Skill Area:
Pharmacovigilance (PV) – Drug Safety & Risk Management
Role Overview:
The Safety & PV Specialist I is responsible for processing and managing safety data, particularly Individual Case Safety Reports (ICSRs). The role ensures accurate data entry, medical coding, narrative writing, and compliance with global regulatory requirements to support drug safety monitoring.
About the Company:
Syneos Health is a fully integrated life sciences organization that supports drug development and commercialization. It collaborates with global innovators to deliver clinical and safety solutions across the drug lifecycle.
Key Responsibilities:
1. Case Processing & Data Entry
Enter and track ICSRs in PV quality and tracking systems
Perform accurate data entry into safety databases
Maintain data quality, completeness, and consistency
2. ICSR Handling & Evaluation
Triage ICSRs and assess reportability
Process cases as per SOPs and safety plans
Identify and manage duplicate ICSRs
Perform quality checks and reviews
3. Medical Coding
Code adverse events, medical history, and medications
Use MedDRA coding for standardization
Maintain and update drug dictionaries
4. Narrative Writing & Query Management
Prepare complete and accurate case narratives
Identify missing information and raise queries
Follow up until resolution of queries
5. Regulatory Reporting
Assist in preparation of expedited safety reports
Ensure compliance with global regulatory timelines
Support xEVMPD submissions and validation
6. Literature Review & Safety Monitoring
Perform literature screening for safety data
Support drug safety surveillance activities
7. Compliance & Documentation
Maintain Trial Master File (TMF) and Pharmacovigilance System Master File (PSMF)
Ensure adherence to SOPs, WIs, and regulatory guidelines
Follow ICH-GCP and GVP standards
8. Advanced PV Activities
Perform manual recoding of products/substances
Support SPOR / IDMP-related activities
9. Collaboration & Audits
Work with internal and external stakeholders
Participate in audits and inspections
Maintain professional communication
Required Skills & Competencies:
Knowledge of Pharmacovigilance and ICSR processing
Medical coding skills (MedDRA)
Strong attention to detail and accuracy
Understanding of regulatory guidelines (ICH, GCP, GVP)
Analytical and problem-solving skills
Good communication and teamwork abilities
Work Environment:
Office-based role
Fast-paced and collaborative work culture
Exposure to global clinical and safety projects
Additional Information:
Immediate joiners preferred
Responsibilities may vary based on project requirements
Equal opportunity employer
Compliance with global employment and regulatory standards
Job description is not exhaustive and may evolve
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