Job Overview
Position: Safety & Pharmacovigilance (PV) Specialist I
Company: Syneos Health
Location: Pune
Job ID: 25107956
Updated: May 15, 2026
Department: Pharmacovigilance / Drug Safety
Level: Entry / Junior Specialist (PV Operations)
About the Company
Syneos Health is a global life sciences services organization supporting pharmaceutical and biotech companies across clinical development, safety, and commercialization.
Key highlights:
Supported 94% of FDA-approved drugs (last 5 years)
Worked on 95% of EMA-authorized products
Delivered services across 73,000+ clinical sites globally
Role Summary
The Safety & PV Specialist I is responsible for:
Processing and managing Individual Case Safety Reports (ICSRs)
Supporting pharmacovigilance operations and safety databases
Ensuring compliance with global drug safety regulations
Performing coding, data entry, and quality review of safety data
This role is foundational in drug safety operations and focuses heavily on case processing accuracy, regulatory compliance, and safety data management.
Key Responsibilities
1. ICSR Case Processing
Enter safety information into PV tracking systems
Process ICSRs as per SOPs and safety management plans
Triages cases for:
Completeness
Accuracy
Regulatory reportability
2. Safety Database Management
Enter data into safety systems
Perform:
Event coding
Medical history coding
Concomitant medication coding
Laboratory test coding
3. Narrative & Query Management
Prepare narrative summaries for safety cases
Identify missing or unclear information
Raise and follow up queries until resolution
4. Regulatory Safety Reporting
Assist in generating expedited safety reports
Ensure compliance with regulatory timelines
Support accurate and timely submissions
5. Literature & Drug Coding Activities
Perform literature screening for safety signals
Maintain:
Drug dictionaries
MedDRA coding standards
Handle recoding of un-coded safety data
6. Advanced Safety Operations
Manage:
xEVMPD product records submission
SPOR / IDMP activities
Identify and manage duplicate ICSRs
Support pharmacovigilance system data integrity
7. Quality & Compliance
Perform quality review of ICSRs
Ensure adherence to:
SOPs
Work Instructions (WIs)
GVP / GCP / ICH guidelines
Support audit readiness activities
8. Documentation & TMF Support
Ensure proper documentation in:
Trial Master File (TMF)
Pharmacovigilance System Master File (PSMF)
Maintain compliance with documentation standards
9. Collaboration & Communication
Work with internal and external stakeholders
Maintain strong professional relationships
Support cross-functional safety operations teams
Required Skills & Knowledge
Pharmacovigilance Expertise
Understanding of:
ICSRs (case processing)
Safety databases
MedDRA coding
Drug dictionaries
Regulatory Knowledge
Knowledge of:
GVP (Good Pharmacovigilance Practices)
GCP (Good Clinical Practice)
ICH guidelines
Global drug safety regulations
Technical Skills
Safety database systems (PV tools)
Data entry accuracy and management
Literature screening tools
Microsoft Office (basic proficiency)
Core Competencies
Strong attention to detail
Ability to manage repetitive data-intensive tasks
Good documentation and tracking skills
Ability to work under timelines
Preferred Attributes
Exposure to pharmacovigilance case processing
Experience with MedDRA coding
Understanding of clinical trial safety reporting
Audit support experience
Soft Skills
Strong communication skills
Team collaboration
Time management
Ability to follow structured SOP-driven workflows
Problem-solving mindset for case clarification
Role Impact
Functional Importance
This role contributes directly to:
Patient safety monitoring
Regulatory compliance
Drug safety signal accuracy
Global pharmacovigilance reporting obligations
Career Progression Path
Typical advancement from this role:
PV Specialist II
Senior PV Specialist
Drug Safety Associate / Scientist roles
PV Team Lead / Case Management Lead
Work Environment & Culture
Why Join Syneos Health?
Exposure to global pharmacovigilance projects
Structured training in drug safety systems
Career development opportunities
Collaborative global life sciences environment
Focus on compliance, quality, and innovation
Functional Areas Covered
Pharmacovigilance (PV)
Drug Safety Operations
ICSR Processing
Regulatory Safety Reporting
Medical Coding (MedDRA)
Clinical Safety Compliance
Ideal Candidate Profile
The ideal candidate should:
Be detail-oriented and process-driven
Understand basic pharmacovigilance concepts
Be comfortable working with safety databases
Follow SOPs and regulatory guidelines strictly
Manage high-volume case processing tasks efficiently
Employment Notes
Additional duties may be assigned as needed
Equivalent experience may be considered
Syneos Health is an equal opportunity employer
Reasonable accommodations available as required
Application
Apply via:
Syneos Health Careers
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