Safety & PV Coordinator (Hyderabad Office-Based)
Company: Syneos Health
Location: Hyderabad, India
Office Location: Hyderabad
Job ID: 25110587
Updated: July 29, 2026
Employment Type: Full-Time
Work Mode: Office-Based
About Syneos Health
Syneos Health® is a leading fully integrated life sciences services organization built to accelerate customer success. The company partners with innovators across the drug development and commercialization continuum, helping them navigate complexity, anticipate change, and accelerate progress.
Syneos Health provides solutions across:
Clinical development
Medical affairs
Commercial services
Patient-focused healthcare innovation
Job Summary
The Safety & PV Coordinator is responsible for supporting pharmacovigilance operations, including:
Individual Case Safety Report (ICSR) processing
Safety database management
Regulatory reporting support
Medical coding activities
Literature review
Post-marketing surveillance (PMS) case handling
Compliance with global safety regulations
Key Responsibilities
ICSR Processing & Case Management
Enter information into PVG quality and tracking systems for receipt and tracking of ICSRs.
Process ICSRs according to:
Standard Operating Procedures (SOPs)
Project-specific safety plans
Triage ICSRs and evaluate:
Completeness
Accuracy
Regulatory reportability
Enter data into safety databases.
Code:
Adverse events
Medical history
Concomitant medications
Medical tests
Prepare complete and accurate narrative summaries.
Identify missing information and follow up on queries until resolution.
Support timely generation of expedited safety reports.
Safety Data Management Activities
Maintain safety tracking for assigned activities.
Perform:
Literature screening
Safety review
Drug coding
Drug dictionary maintenance
MedDRA coding
Perform validation and submission of:
xEVMPD product records
Indication term coding using MedDRA
Perform manual recoding of:
Uncoded product terms
Uncoded substance terms from ICSRs
Identify and manage duplicate ICSRs.
Support SPOR / IDMP activities.
Perform quality review of ICSRs.
Regulatory Compliance & Documentation
Ensure submission of relevant documents to:
Trial Master File (TMF) for clinical trials
Pharmacovigilance System Master File (PSMF) for post-marketing programs
Maintain compliance with:
SOPs
Work Instructions (WIs)
GCP
ICH guidelines
GVP requirements
Drug, biologic, and device regulations
Participate in audits when required.
Apply safety reporting regulatory intelligence to assigned activities.
Collaboration & Communication
Build effective working relationships with:
Internal project teams
External stakeholders
Clients
Communicate safety-related information clearly.
Work independently and collaboratively within project teams.
Required Qualifications
Education
Required:
B.Pharm
M.Pharm
Experience Requirements
Minimum 1 year of experience in:
Post-Marketing Surveillance (PMS)
Spontaneous case processing
Technical Skills & Knowledge
Preferred safety databases:
LSMV
Argus experience acceptable
Required knowledge:
Safety database systems
Medical terminology
Clinical trial processes (Phase II–IV)
Post-marketing safety requirements
ICH-GCP guidelines
GVP regulations
Pharmacovigilance regulations
Software Skills
Proficiency in:
Microsoft Word
Microsoft Excel
Microsoft PowerPoint
Visio
Outlook email
Team Share / document management platforms
Internet-based systems
Key Competencies
Strong attention to detail and accuracy
Ability to manage multiple tasks and priorities
Good organizational skills
Ability to meet deadlines
Independent working ability
Strong written and verbal communication skills
Effective teamwork and collaboration skills
About Syneos Health
Syneos Health has supported:
94% of Novel FDA Approved Drugs
95% of EMA Authorized Products
200+ studies across 73,000 sites
675,000+ clinical trial patients
Syneos Health focuses on:
Career development
Technical training
Inclusive culture
Global collaboration
Application Information
Position: Safety & PV Coordinator
Location: Hyderabad, India
Qualification: B.Pharm / M.Pharm
Experience: Minimum 1 year PMS & Spontaneous Case experience
Database Preference: LSMV / Argus
Apply through the Syneos Health careers portal.
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