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 managing and processing safety data, including Individual Case Safety Reports (ICSRs). The role ensures accurate data entry, medical coding, regulatory compliance, and timely safety reporting to support patient safety and drug risk evaluation.
About the Company:
Syneos Health is a fully integrated life sciences services organization that supports drug development and commercialization. The company collaborates with global pharmaceutical innovators to accelerate clinical and safety solutions across the product lifecycle.
Key Responsibilities:
1. Case Processing & Data Management
Enter and track ICSRs in PV systems
Perform data entry into safety databases
Maintain accuracy, completeness, and consistency of safety data
2. ICSR Handling & Evaluation
Triage ICSRs and assess regulatory reportability
Process cases as per SOPs and safety management plans
Identify and manage duplicate cases
Perform quality review of ICSRs
3. Medical Coding & Documentation
Code adverse events, medical history, and concomitant medications
Use MedDRA coding for standardization
Maintain and update drug dictionaries
4. Narrative Writing & Query Management
Prepare detailed case narratives
Identify missing or unclear data and raise queries
Follow up for query resolution
5. Regulatory Reporting
Assist in preparation and submission of expedited safety reports
Ensure compliance with global regulatory requirements
Support xEVMPD submissions and validation
6. Literature Review & Signal Support
Perform literature screening for safety data
Support drug safety monitoring activities
7. Compliance & Documentation
Maintain Trial Master File (TMF) and Pharmacovigilance System Master File (PSMF)
Ensure compliance with SOPs, WIs, and regulatory guidelines
Follow ICH-GCP and GVP standards
8. Advanced PV Activities
Perform manual recoding of products/substances
Handle SPOR / IDMP-related activities
9. Collaboration & Audits
Coordinate with internal and external stakeholders
Participate in audits and inspections
Maintain professional communication
Required Skills & Competencies:
Strong knowledge of Pharmacovigilance and ICSR processing
Medical coding expertise (MedDRA)
Attention to detail and accuracy
Understanding of global regulations (ICH, GCP, GVP)
Analytical and problem-solving skills
Effective communication and teamwork
Work Environment:
Office-based role (Gurugram/Hyderabad)
Dynamic and fast-paced environment
Collaborative team structure
Additional Information:
Immediate joiners preferred
Responsibilities may vary based on project needs
Equal opportunity employer with inclusive work culture
No employment contract implied in the job description
Compliance with global employment and disability regulations
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