Job Overview
Position: Safety & Pharmacovigilance (PV) Specialist I
Company: Syneos Health
Location: Hyderabad
Job ID: 25107956
Updated: May 15, 2026
Function: Pharmacovigilance / Drug Safety
Level: Entry-level / Specialist I
About the Company
Syneos Health is a global life sciences organization focused on accelerating clinical development, safety monitoring, and commercialization of therapies.
Key highlights:
Supported 94% of FDA-approved drugs in the last 5 years
Worked on 95% of EMA-authorized products
Delivered clinical and safety services across 73,000+ sites globally
Role Summary
The Safety & PV Specialist I is responsible for:
Processing and managing Individual Case Safety Reports (ICSRs)
Supporting pharmacovigilance case intake and evaluation
Ensuring regulatory compliance for drug safety reporting
Performing coding, data entry, and quality review of safety data
This role is highly process-driven and forms the backbone of global drug safety operations.
Key Responsibilities
1. ICSR Processing & Data Entry
Enter safety data into PV tracking systems
Process ICSRs per SOPs and project safety plans
Ensure accurate case intake and documentation
2. Case Triage & Evaluation
Assess ICSRs for:
Completeness
Accuracy
Regulatory reportability
Identify missing or inconsistent information
3. Safety Database Management
Enter and maintain safety data in databases
Code:
Adverse events
Medical history
Concomitant medications
Laboratory tests
4. Narrative Writing & Query Handling
Prepare complete case narrative summaries
Raise queries for missing data
Follow up until resolution and closure
5. Regulatory Safety Reporting
Support expedited reporting activities
Ensure compliance with global regulatory timelines
Assist in submission of safety reports
6. Literature & Coding Activities
Perform literature screening for safety information
Maintain:
Drug dictionaries
MedDRA coding systems
Handle manual recoding of un-coded terms
7. Advanced PV Activities
Manage:
xEVMPD product record validation and submission
SPOR / IDMP-related activities
Identify and resolve duplicate ICSRs
8. Quality & Compliance
Conduct quality review of ICSRs
Ensure adherence to:
SOPs
Work Instructions (WIs)
GVP / GCP / ICH guidelines
Support audit readiness activities
9. Documentation & Regulatory Filing
Ensure proper submission of documents to:
Trial Master File (TMF)
Pharmacovigilance System Master File (PSMF)
Maintain compliance documentation standards
10. Collaboration & Communication
Work with internal and external stakeholders
Maintain professional relationships across teams
Support cross-functional safety operations
Required Skills & Knowledge
Pharmacovigilance Expertise
Understanding of:
ICSRs (case processing lifecycle)
Safety database systems
MedDRA coding
Drug dictionaries and coding principles
Regulatory Knowledge
Knowledge of:
GVP (Good Pharmacovigilance Practices)
GCP (Good Clinical Practice)
ICH guidelines
Global drug safety regulations
Technical Skills
PV databases and tracking tools
Data entry accuracy and validation
Literature screening tools
Microsoft Office (basic proficiency)
Core Competencies
High attention to detail
Strong documentation skills
Ability to follow SOP-driven workflows
Time management under strict timelines
Analytical thinking for case evaluation
Preferred Qualifications
Exposure to pharmacovigilance operations
Experience with MedDRA coding
Understanding of clinical trial safety reporting
Knowledge of audit processes in PV
Soft Skills
Strong written and verbal communication
Team collaboration mindset
Ability to work in structured processes
Problem-solving for case clarifications
Reliability in high-volume data work
Role Impact
Functional Importance
This role directly contributes to:
Patient safety monitoring
Regulatory compliance
Drug safety signal detection
Global pharmacovigilance reporting
Career Growth Path
Typical progression:
PV Specialist II
Senior PV Specialist
Drug Safety Associate / Scientist
PV Lead / Case Management Lead
Work Environment & Culture
Why Join Syneos Health?
Exposure to global pharmacovigilance systems
Structured training in drug safety operations
Career development opportunities
Collaboration across global life sciences teams
Strong focus on compliance and quality
Functional Areas Covered
Pharmacovigilance (PV)
Drug Safety Operations
ICSR Case Processing
Regulatory Safety Reporting
Medical Coding (MedDRA)
Clinical Compliance
Ideal Candidate Profile
The ideal candidate should:
Be detail-oriented and process-driven
Understand basic pharmacovigilance principles
Be comfortable working with structured SOPs
Handle repetitive, high-accuracy tasks
Maintain compliance under strict timelines
Employment Notes
Additional responsibilities may be assigned as needed
Equivalent experience may be considered
Syneos Health is an equal opportunity employer
Reasonable accommodations are provided where applicable
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